BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4951569 · Received July 28, 2015

    Report

    Report Number
    3007981285-2015-50093
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 6, 2015
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED. T:SLIM USER GUIDE INDICATES, THE CARTRIDGE IS INDICATED AS A RESERVOIR FOR THE DELIVERY OF RAPID-ACTING INSULIN, HUMALOG WAS TESTED FOR UP TO 48 HOURS OF USE AS LABELED. THE CARTRIDGE IS CONTRAINDICATED FOR USE WITH PRODUCTS OTHER THAN HUMALOG AND NOVOLOG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS (200-400 MG/DL), AND SMALL KETONES PRESENT. TROUBLESHOOTING WAS PERFORMED AND PUMP APPEARS TO BE FUNCTIONING AS EXPECTED. CARTRIDGE AND INFUSION SET ARE CHANGED EVERY 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488620 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other INFUSION SET: UNOMEDICAL INSET| INSULIN: HUMALOG