BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5533416 · Received March 29, 2016

    Report

    Report Number
    3007981285-2016-73531
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    March 3, 2016
    Report Date
    March 7, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 BY THE CONTACT THAT THE CUSTOMER HAD EXPERIENCED BLOOD GLUCOSE (BG) LEVELS RANGING 200-497 MG/DL. AFTER CHANGING THE PUMP SUPPLIES, A CORRECTION BOLUS AND INSULIN INJECTIONS WERE USED TO ADDRESS THE HIGH BG LEVEL. THE CONTACT WAS WORKING WITH THE HEALTHCARE PROVIDER WITH ADJUSTING THE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186978 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other