BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4961464 · Received July 30, 2015

    Report

    Report Number
    3007981285-2015-50746
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    July 19, 2015
    Report Date
    July 19, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 A BLOOD GLUCOSE (BG) VALUE OF 350 MG/DL WAS ENTERED INTO THE PUMP AFTER TESTING, AND A BOLUS WAS DELIVERED. BG LEVEL WAS TESTED AGAIN AFTER CUSTOMER WASHED HIS HANDS (CONTACT BELIEVED THAT CUSTOMER HAD SOMETHING ON HIS HANDS CAUSING ELEVATED BG VALUE) AND BG VALUE WAS 230 MG/DL. CONTACT WANTED TO CANCEL THE BOLUS. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, CONTACT UNDERSTOOD THAT THE BOLUS COULD NOT BE CANCELED. CONTACT INDICATED THAT CUSTOMER WOULD EAT CARBS TO COUNTER THE BOLUS DELIVERY. CONTACT REPORTED THAT THE DEVICE HAD PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495595 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other