BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6089138 · Received November 9, 2016

    Report

    Report Number
    3007981285-2016-18369
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 A MALFUNCTION ALARM OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 177 (MG/DL). IT WAS INDICATED THAT THE CUSTOMER WOULD USE INSULIN PENS AND LANTUS AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740976 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR