BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7065039 · Received November 28, 2017

    Report

    Report Number
    3007981285-2017-35530
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 28, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M021018). THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER LOADED A NEW CARTRIDGE AND DID NOT OBSERVE DROPS EXITING FROM THE INFUSION SET TUBING DURING THE FILL TUBING STEP. THE CUSTOMER ATTEMPTED TO FILL THE TUBING AND OBSERVED DROPS EXITING AFTER FILLING WITH 15 UNITS; HOWEVER, RECEIVED A MINIMUM FILL MESSAGE. REPORTEDLY, THE CARTRIDGE HAD BEEN FILLED WITH 200 UNITS OF INSULIN. THE CUSTOMER ATTEMPTED LOAD A NEW CARTRIDGE, BUT ADDITIONAL MINIMUM FILL MESSAGES OCCURRED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844529 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M020446

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR