BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 7324734 · Received March 8, 2018

    Report

    Report Number
    3013756811-2018-07158
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 8, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL LOT NUMBER WAS REPORTED (LOT # M020176). 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED MALFUNCTION WAS VERIFIED AND A DIFFERENT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARM 1 (NO PRESSURE CHANGE WHEN EXPECTED) OCCURRED DURING PUMPING WITH MULTIPLE CARTRIDGES. BLOOD GLUCOSE LEVEL RANGED FROM 293-353 MG/DL. REPORTEDLY, THE CUSTOMER DECLINED TO LOAD A NEW CARTRIDGE AND REVERTED TO MANUAL INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166045 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 M020876

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR