BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4397419 · Received January 7, 2015

    Report

    Report Number
    3007981285-2015-17152
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    December 11, 2014
    Report Date
    December 11, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT# M003855); HOWEVER, THE CAUSE OF THE EVEN IS NOT DUE TO THE CARTRIDGE. THE DEVICE HAS BEEN RECEIVED FOR EVAL; HOWEVER, DEVICE EVAL IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVAL.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13457 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES CARE INC. 004628 M002603

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR