BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 15921546 · Received December 5, 2022

    Report

    Report Number
    3004464228-2022-22766
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 10, 2022
    Report Date
    November 10, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000009
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PDM WAS RETURNED AND A VISUAL INSPECTION WAS PERFORMED; NO ABNORMALITIES WERE OBSERVED. A TECHNICAL ASSESSMENT OF THE DEVICE DESIGN IDENTIFIED THE ROOT CAUSE OF THE BATTERY EVENT TO BE THE DASH PDM CHARGING VOLTAGE EXCEEDING THE BATTERY SPECIFICATION, DEFINED AS OVERCHARGING. FIELD SAFETY CORRECTIVE ACTION HAS BEEN INITIATED BY INSULET CORPORATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 010300-11655. CORRECTION TO H(3) :DEVICE RETURNED TO MANUFACTURER CHANGED FROM NO TO YES. DEVICE EVALUATED BY MANUFACTURER UPDATED CHANGED FROM NO TO YES. CORRECTION TO H(6) INVESTIGATION FINDINGS UPDATED TO C0201. INVESTIGATION CONCLUSIONS UPDATED TO D0108.

    Additional Manufacturer Narrative · 0

    A TECHNICAL ASSESSMENT OF THE DEVICE DESIGN IDENTIFIED THE ROOT CAUSE OF THE BATTERY EVENT TO BE THE DASH PDM CHARGING VOLTAGE EXCEEDING THE BATTERY SPECIFICATION, DEFINED AS OVERCHARGING. FIELD SAFETY CORRECTIVE ACTION HAS BEEN INITIATED BY INSULET CORPORATION. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) IS LOSING A BATTERY CHARGE QUICKER THAN EXPECTED. THE PATIENT REPORTED THAT THEIR BATTERY WAS BULGING FROM THE BACK OF THE PDM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947134 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18239 L000323 10385082000009

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female