BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4142677 · Received October 2, 2014

    Report

    Report Number
    3007981285-2014-08684
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CARTRIDGES ARE LABELED FOR NO MORE THAN THREE DAY USE; CUSTOMER CHANGED CARTRIDGES EVERY FIVE DAYS. IN ADDITION, THE T:SLIM PUMP USER GUIDE CAUTIONS THAT THE INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING CARTRIDGE. FINALLY, HUMALOG IS LABELED FOR 2 DAY USE IN INSULIN PUMP CARTRIDGES. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER MULTIPLE OCCLUSION ALARMS. REPORTEDLY, CUSTOMER'S BLOOD GLUCOSE LEVEL WAS HIGH (400'S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614836 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other