BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7522419 · Received May 17, 2018

    Report

    Report Number
    3013756811-2018-16564
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    April 27, 2018
    Report Date
    May 17, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL CARTRIDGE LOT NUMBER WAS REPORTED (LOT #M021181). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CUSTOMER RECEIVED MULTIPLE INACCURATE FILL ESTIMATES DISPLAYED ON THE PUMP INSULIN GAUGE WITH MULTIPLE CARTRIDGES. THE INSULIN GAUGE DISPLAYED AN INACCURATE FILL ESTIMATE OF 105 UNITS AND REMAINED STATIC. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH AROUND 300 UNITS OF INSULIN. THE CUSTOMER'S BLOOD GLUCOSE WAS 208 MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366365 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096 M021314

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR