BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3946294 · Received July 7, 2014

    Report

    Report Number
    3007981285-2014-02335
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING CARTRIDGE PIGTAIL LUER SEPARATING FROM THE CARTRIDGE. CUSTOMERS' BLOOD GLUCOSE LEVEL WAS IMPACTED. CUSTOMER IS UNSURE WHICH LOT NUMBER WAS USED AT THE TIME OF EVENT. CUSTOMER BELIEVES IT IS EITHER M002626, M002946 OR M001662.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393099 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other