BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8840677 · Received July 30, 2019

    Report

    Report Number
    3013756811-2019-43444
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    July 6, 2019
    Report Date
    July 30, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DECLARED MULTIPLE, INTERMITTENT TEMPERATURE ALARMS WHILE THE CUSTOMER WAS CHARGING AND NOT CHARGING THE PUMP. CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 200-508 MG/DL. A MANUAL INJECTION WAS ADMINISTERED TO ADDRESS BG. REPORTEDLY, THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES AND THE ALARMS CONTINUED TO OCCUR. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635494 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other