BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6206784 · Received December 27, 2016

    Report

    Report Number
    3007981285-2016-27803
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WAKE BUTTON HAS STOPPED FUNCTIONING. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS CONFIRMED THAT THE PUMP STILL TURNS ON WHEN PLUGGED INTO A POWER SOURCE. IN ADDITION, THE PUMP UNEXPECTEDLY RESET. CUSTOMER REPORTED BLOOD GLUCOSE LEVEL WAS 210-317 (MG/DL) WITH TRACE KETONES. A MANUAL INJECTION WAS DELIVERED TO ADDRESS BG LEVEL. REPORTEDLY THE CUSTOMER WILL USE MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY UNTIL THE REPLACEMENT PUMP IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856379 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other