BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5854860 · Received August 8, 2016

    Report

    Report Number
    3007981285-2016-94697
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    July 14, 2016
    Report Date
    July 16, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN GAUGE HAD REMAINED STATIC FOR APPROXIMATELY TWO DAYS, AFTER FILLING THE CARTRIDGE WITH APPROXIMATELY 230-220 UNITS OF INSULIN. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER WAS NOT WILLING TO TROUBLESHOOT THE ISSUE DURING THE INITIAL REPORT. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT; HOWEVER, THE CUSTOMER DID NOT RESPOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506494 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR