BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3994229 · Received July 24, 2014

    Report

    Report Number
    3007981285-2014-03633
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 FOLLOW UP SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS ULTIMATELY RECEIVED.

    Description of Event or Problem · 1

    RECEIVED INFO REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING BOLUS DELIVERY. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433839 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003288

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR