BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6538462 · Received May 2, 2017

    Report

    Report Number
    3007981285-2017-11830
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    April 10, 2017
    Report Date
    May 2, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING THE LOAD SEQUENCE. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED BETWEEN HIGH 200-382 MG/DL. MANUAL INJECTIONS WERE ADMINISTERED AND PUMP SUPPLIES WERE CHANGED TO ADDRESS THE BG LEVELS. THE CUSTOMER REPORTED THAT MANUAL INJECTIONS WOULD BE USED FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317418 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other