BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6196423 · Received December 21, 2016

    Report

    Report Number
    3007981285-2016-27581
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    December 14, 2016
    Report Date
    December 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. DEVICE NOT RETURNED.

    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 LEVEL WAS 137 MG/DL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED AND INSULIN DELIVERY WAS RESUMED. REPORTEDLY, THE CUSTOMER WOULD CONTINUE USE OF THE CURRENT PUMP UNTIL THE REPLACEMENT PUMP WAS RECEIVED BUT ALSO HAS MANUAL INJECTIONS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843468 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR