BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6110134 · Received November 17, 2016

    Report

    Report Number
    3007981285-2016-19390
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 27, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP BATTERY WAS OBSERVED TO BE DEPLETING QUICKLY FOR THE PAST TWO WEEKS. THE PUMP BATTERY DEPLETED FROM 100% TO 10% WITHIN 2 DAYS. THE CUSTOMER ALSO STATED THE PUMP SHUT DOWN DUE TO THE BATTERY DEPLETION. THE PUMP WAS CONNECTED TO A POWER SOURCE AND ABLE TO BE TURNED ON. CUSTOMER REPORTED BLOOD GLUCOSE (BG) LEVEL WAS 324 (MG/DL). THE CUSTOMER STATED A BOLUS VIA THE PUMP AND ORAL MEDICATION WOULD BE TAKEN TO ADDRESS BG LEVEL. REPORTEDLY THE CUSTOMER WILL CONTINUE TO USE THE PUMP UNTIL THE REPLACEMENT PUMP IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759847 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other