BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7990645 · Received October 22, 2018

    Report

    Report Number
    3013756811-2018-37460
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 22, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 MULTIPLE MALFUNCTION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM (110-165) MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831502 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR