BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5329689 · Received December 28, 2015

    Report

    Report Number
    3007981285-2015-64260
    Event Type
    Injury
    Date Received
    December 28, 2015
    Date of Event
    December 6, 2015
    Report Date
    December 7, 2015
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND ELEVATED BLOOD GLUCOSE (BG) LEVELS (120-509 MG/DL). PRIOR TO HOSPITALIZATION, PUMP BOLUSES AND BASAL DELIVERY WERE USED TO ADDRESS ELEVATED LEVELS. SYSTEM CHECK INDICATED THAT THE PUMP WAS PERFORMING AS INTENDED. CONTACT DID NOT ATTRIBUTE THE ADVERSE IMPACT TO THE PUMP OR SUPPLIES; HOWEVER, THE CAUSE WAS NOT DETERMINED. CUSTOMER WAS RUNNING A FEVER AND VOMITING PRIOR TO DEVELOPING ELEVATED BG LEVELS. CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN AND FLUIDS, BLOOD TESTS, LABS EVERY FOUR HOURS, AND URINE TEST TO CHECK FOR KETONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854096 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization| L| R INFUSION SET: INSET, INSULIN: NOVOLOG