BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2, BASAL-IQ, MMOL/L

    MDR report key: 10862305 · Received November 18, 2020

    Report

    Report Number
    3013756811-2020-125011
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 18, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 AND EVALUATION IS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE EMPTY CARTRIDGE ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE WAS 162-306 MG/DL. CUSTOMER REVERTED TO USING AN ALTERNATE METHOD OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327228 T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1