BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3842680 · Received May 19, 2014

    Report

    Report Number
    3007981285-2014-00696
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 19, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D FOR EVALUATION; HOWEVER, EVALUATION IS NOT YET COMPLETE. A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REC'D INFO STATING CUSTOMER HAD NOT CHARGED THE PUMP IN 7 DAYS AND PUMP BATTERY DIED THROUGHOUT THE NIGHT. WHEN THE CUSTOMER PLUGGED THE PUMP INTO THE POWER SOURCE, THE PUMP WOULD BEEP AND VIBRATES BUT DID NOT ILLUMINATE. THE PUMP HAD GOTTEN WET TWO DAYS PRIOR. REPORTEDLY, THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295053 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other