BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4961986 · Received July 31, 2015

    Report

    Report Number
    3007981285-2015-50437
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CARTRIDGE ALARM 1. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499115 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES CARE 004628 M015494

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR