Items tagged #adverse-event
Reported to the FDA Oct 29, 2026 (event Feb 13, 2025). The FDA publishes these reports weeks after receipt. The customer reported a Sample Presentation Unit (SPU) motion error on a UniCel DxI 800 Access Immunoassay Analyzer, Product Number 973100, Serial Number (b)(6). As reported, patie
Reported to the FDA Oct 28, 2026 (event Jun 23, 2026). The FDA publishes these reports weeks after receipt. Philips identified a software defect internally in Intellispace Cardiovascular (ISCV) wherein when a user logs out of the application, the authenticated session token remains valid
Reported to the FDA Oct 28, 2026 (event Jul 1, 2026). The FDA publishes these reports weeks after receipt. Philips identified a software defect internally in Intellispace Cardiovascular (ISCV) wherein the system does not require a second step of verification (multi-factor authentication
Reported to the FDA Oct 28, 2026 (event Jul 1, 2026). The FDA publishes these reports weeks after receipt. Philips identified a software defect internally in Intellispace Cardiovascular (ISCV) wherein the ISCV is shipped with unsigned binaries, installers, and scripts. The device was ou
Reported to the FDA Oct 28, 2026 (event Jul 1, 2026). The FDA publishes these reports weeks after receipt. Philips identified a software defect internally in Intellispace Cardiovascular (ISCV) wherein in trusted domain mode, if two users from different trusted domains share the same use
Reported to the FDA Oct 26, 2026 (event Oct 12, 2026). The FDA publishes these reports weeks after receipt. I am a type 1 diabetic and rely heavily on the Dexcom G7 Continuous Glucose Monitor\in my disease management. I have used the Dexcom G7 for about 2 weeks, but have\used other Dexco
Reported to the FDA Oct 23, 2026 (event Sep 16, 2026). The FDA publishes these reports weeks after receipt. A third-party reported to Abbott Diabetes Care (ADC) of a cybersecurity vulnerability with the Lingo application. The cybersecurity vulnerability was identified to affect communica
Reported to the FDA Oct 23, 2026 (event Sep 16, 2026). The FDA publishes these reports weeks after receipt. A third-party reported to Abbott Diabetes Care (ADC) of a cybersecurity vulnerability with the Libre Application. The cybersecurity vulnerability was identified to affect communica
Reported to the FDA Oct 23, 2026 (event Sep 16, 2026). The FDA publishes these reports weeks after receipt. A third-party reported to Abbott Diabetes Care (ADC) of a cybersecurity vulnerability with the FreeStyle Libre 3 application. The cybersecurity vulnerability was identified to affe
Reported to the FDA Oct 22, 2026 (event Oct 1, 2026). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Reported to the FDA Oct 16, 2026 (event Sep 17, 2026). The FDA publishes these reports weeks after receipt. A review of the complaint history for SN (b)(6)was performed in Salesforce which did not locate similar complaint(s) with the same failure mode for this serial number.\\A review of
Reported to the FDA Oct 16, 2026 (event Jun 23, 2026). The FDA publishes these reports weeks after receipt. Philips identified a software defect internally in IntelliSpace Cardiovascular (ISCV) whereby the thick client application does not adequately distinguish between legitimate and ma
Reported to the FDA Oct 16, 2026 (event Jul 1, 2026). The FDA publishes these reports weeks after receipt. Philips identified a software defect internally in IntelliSpace Cardiovascular (ISCV) wherein the application uses an outdated version of ASP.NET in the Service Tool, which may exp
Reported to the FDA Oct 16, 2026 (event Jul 1, 2026). The FDA publishes these reports weeks after receipt. Philips identified a software defect internally in IntelliSpace Cardiovascular (ISCV) whereby ISCV users could browse image repository folders and navigate to patient folders conta
Reported to the FDA Oct 16, 2026 (event May 15, 2026). The FDA publishes these reports weeks after receipt. D4 & H4: Serial number, Catalog, Model, Unique Device Identifier and Manufacturer Date not available.\\A device evaluation is anticipated but has not yet begun. Upon completion of
Reported to the FDA Oct 12, 2026 (event Sep 15, 2026). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Reported to the FDA Oct 7, 2026. The FDA publishes these reports weeks after receipt. EDAN has identified a cybersecurity vulnerability that could allow an attacker to gain access privileges by placing a host on the same broadcast domain as the device. The vulnerabi
Reported to the FDA Oct 7, 2026. The FDA publishes these reports weeks after receipt. EDAN has identified a cybersecurity vulnerability that could allow an attacker to gain access privileges by placing a host on the same broadcast domain as the device. The vulnerabi
Reported to the FDA Oct 7, 2026. The FDA publishes these reports weeks after receipt. EDAN has identified a cybersecurity vulnerability that could allow an attacker to gain access privileges by placing a host on the same broadcast domain as the device. The vulnerabi
Reported to the FDA Oct 7, 2026. The FDA publishes these reports weeks after receipt. EDAN has identified a cybersecurity vulnerability that could allow an attacker to gain access privileges by placing a host on the same broadcast domain as the device. The vulnerabi
Reported to the FDA Oct 7, 2026. The FDA publishes these reports weeks after receipt. EDAN has identified a cybersecurity vulnerability that could allow an attacker to gain access privileges by placing a host on the same broadcast domain as the device. The vulnerabi
Reported to the FDA Oct 7, 2026. The FDA publishes these reports weeks after receipt. EDAN has identified a cybersecurity vulnerability that could allow an attacker to gain access privileges by placing a host on the same broadcast domain as the device. The vulnerabi
Reported to the FDA Oct 6, 2026 (event Sep 18, 2026). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Reported to the FDA Oct 2, 2026 (event Sep 21, 2026). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Reported to the FDA Sep 30, 2026 (event Aug 12, 2026). The FDA publishes these reports weeks after receipt. On (b)(6) 2026 the patient received UltraClear treatment. According to the patient impact form completed by the clinic, the treating physician immediately noticed that there was a
Reported to the FDA Sep 25, 2026. The FDA publishes these reports weeks after receipt. Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was Pt stated that they had a couple MRIs done of their lower back
Reported to the FDA Sep 11, 2026 (event Aug 15, 2026). The FDA publishes these reports weeks after receipt. Sensor (b)(6)has been returned and investigated. Visual inspection performed on the returned sensor patch and no issue was observed. Data was extracted using approved software and
Reported to the FDA Sep 7, 2026 (event Mar 24, 2026). The FDA publishes these reports weeks after receipt. Philips reviewed the reported complaint requesting ISCV design such that there is no direct connection required to database from thick client.Based on the results of the investigat
Reported to the FDA Sep 8, 2026 (event Apr 7, 2026). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Reported to the FDA Sep 29, 2026 (event Sep 2, 2026). The FDA publishes these reports weeks after receipt. D.4 & H.4: Serial Number, Unique Device Identifier, and Manufacturer Date not available.Upon investigation of the actual device used in this incident, it was determined that the fa
Reported to the FDA Sep 25, 2026 (event Jan 20, 2025). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Reported to the FDA Sep 22, 2026 (event Dec 6, 2024). The FDA publishes these reports weeks after receipt. The customer reported receiving unexpectedly high Access hsTnI (Part Number B52699) patient results on an Access 2 Analyzer (serial number (b)(6)). No adverse patient impact, injur
Reported to the FDA Sep 8, 2026 (event Aug 26, 2026). The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Analysis synthesis:Review of the software analysis confirmed the reported behavior during the LBBOT procedure, with spontaneous QRS complexes incorrectly detected as pacing spikes, leading to inappropriate measurements.The investigation showed that a specific QRS morphology on le
Reported to the FDA Aug 19, 2026. The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
Information was received from a patient who was implanted with an implantable neurostimulator (INS) for urinary/bowel dysfunction. It was reported that since they started having bronchitis in (b)(6) of this year, their therapy wouldn't let them go past 1.3 mA. The patient attempt
NA. ARC-One Solutions received information regarding Regulated Software Application (RSA), Version 2.0 (BK200512). Specifically, an issue related to importing blood products into RSA 2.0 from a blood center's own facility, and the ability to ship these products to customers for
It was reported by the patient that they received a letter from Medtronic indicating that there was a personal data breach. The Impl antable Pulse Generator (IPG) remains in use. No patient complications have been reported as a result of this event. Correction: B5 Medtronic subm
Reported to the FDA Aug 24, 2026. The FDA publishes these reports weeks after receipt. A user alleged hacking; the report contains no confirmed cybersecurity finding.
