BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4795077 · Received May 22, 2015

    Report

    Report Number
    3007981285-2015-30761
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 23, 2015
    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#: M013622). 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 RECEIVED.

    Description of Event or Problem · 1

    RECEIVED INFO REGARDING A CARTRIDGE ALARM 19 DURING BASAL DELIVERY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. THE CUSTOMER WAS ABLE TO LOAD A NEW CARTRIDGE SUCCESSFULLY AND RESUME INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337477 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M010737

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR