BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4742580 · Received April 29, 2015

    Report

    Report Number
    3007981285-2015-28029
    Event Type
    Malfunction
    Date Received
    April 29, 2015
    Date of Event
    March 30, 2015
    Report Date
    March 31, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M003379). 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 INFORMATION 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 BACK UP METHOD OF INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280424 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003378

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR