BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4561848 · Received February 27, 2015

    Report

    Report Number
    3007981285-2015-22088
    Event Type
    Malfunction
    Date Received
    February 27, 2015
    Date of Event
    February 1, 2015
    Report Date
    February 1, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADD'L LOT NUMBER WAS REPORTED (LOT # M013875). THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN REC'D. A F/U SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE HAS BEEN REC'D.

    Description of Event or Problem · 1

    REC'D INFO REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING BOLUS DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140677 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M005016

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR