BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3874980 · Received June 2, 2014

    Report

    Report Number
    3007981285-2014-00925
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN REC'D. A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REC'D INFO REGARDING A CARTRIDGE ALARM 19 DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED. REPORTEDLY, THE CUSTOMER REUSED CARTRIDGES AND THE INSULIN WAS DEGRADED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321863 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M002712

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other