BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6169628 · Received December 13, 2016

    Report

    Report Number
    3007981285-2016-24050
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    November 26, 2016
    Report Date
    November 26, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 AN ALTITUDE ALARM OCCURRED. THE USER¿S BLOOD GLUCOSE (BG) LEVEL WAS 415 MG/DL. THE BG LEVEL WAS ADDRESSED WITH MANUAL INJECTIONS. THERE WAS A DELAY IN CLEARING THE ALARM; HOWEVER, INSULIN DELIVERY WAS RESUMED. A FOLLOW UP WITH THE USER INDICATED THAT THE BG LEVEL LOWERED TO TARGET RANGE AT 120 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820811 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other