BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7874611 · Received September 13, 2018

    Report

    Report Number
    3013756811-2018-31273
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 21, 2018
    Report Date
    September 13, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    852162004361476037
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. BLOOD GLUCOSE LEVEL WAS 240-280 (MG/DL). REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715487 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 852162004361476037

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR