BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVER SYSTEM

    MDR report key: 4382163 · Received December 31, 2014

    Report

    Report Number
    3007981285-2014-16672
    Event Type
    Malfunction
    Date Received
    December 31, 2014
    Date of Event
    December 6, 2014
    Report Date
    December 7, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBERS WERE REPORTED (LOT # M003163, M002602). HOWEVER, THE CAUSE OF THE EVENT IS NOT DUE TO THE CARTRIDGES. 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 HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    RECEIVED INFO REGARDING MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. CUSTOMER REVERTED TO A TRAVEL LOANER PUMP AND WAS ABLE TO SUCCESSFULLY LOAD A NEW CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863596 TANDEM T:SLIM INSULIN DELIVER SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M001738

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR