BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5509259 · Received March 17, 2016

    Report

    Report Number
    3007981285-2016-71488
    Event Type
    Injury
    Date Received
    March 17, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 23, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL (BG 190-312 MG/DL) AND A BOLUS VIA THE PUMP WAS USED TO ADDRESS THE HIGH BG LEVEL. TANDEM TECHNICAL PERFORMED TROUBLESHOOTING AND THE PUMP WAS FOUND TO BE FUNCTIONING AS EXPECTED AND THE SITE MAY POSSIBLY THE CAUSE OF THE HIGH BG. THE CUSTOMER INDICATED THAT THE SITE AND CARTRIDGE WOULD BE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165044 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M016363

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other