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205 results
FDA · FDA event 98475
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin…
Posted Apr 29, 2026
FDA · FDA event 98707
The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Posted Apr 29, 2026
FDA · FDA event 98586
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to…
Posted Apr 10, 2026
FDA · FDA event 98528
it was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI) include certain icons displayed in the status bar that are active, thereby allowing the user to bypass those…
Posted Apr 10, 2026
FDA · FDA event 98540
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
Posted Apr 2, 2026
FDA · FDA event 98537
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Posted Mar 26, 2026
FDA · FDA event 98250
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
Posted Mar 26, 2026
FDA · FDA event 98478
The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion…
Posted Mar 25, 2026
FDA · FDA event 98444
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in…
Posted Mar 24, 2026
FDA · FDA event 98342
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Posted Mar 10, 2026