BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10976579 · Received December 9, 2020

    Report

    Report Number
    3013756811-2020-139186
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 19, 2020
    Report Date
    December 9, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE PUMP TOUCHSCREEN WAS CRACKED AND UNRESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 162-199 MG/DL.. THE CUSTOMER REVERTED TO ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445245 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1