BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5471828 · Received March 1, 2016

    Report

    Report Number
    3007981285-2016-70678
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    January 15, 2016
    Report Date
    February 15, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBER WERE REPORTED (LOT# M016417, M013962).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

    RECEIVED INFORMATION REGARDING MULTIPLE, INTERMITTENT CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. THE CUSTOMER WAS ABLE TO LOAD A NEW CARTRIDGE SUCCESSFULLY AND RESUME INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127961 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M015864

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR