BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10391669 · Received August 11, 2020

    Report

    Report Number
    3013756811-2020-83542
    Event Type
    Malfunction
    Date Received
    August 11, 2020
    Date of Event
    July 22, 2020
    Report Date
    August 11, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00085006613373
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER FILLING THE CARTRIDGE WITH 210-215 UNITS OF INSULIN. CUSTOMER¿S BLOOD GLUCOSE RANGED FROM 125-130 MG/DL. REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE AS ALTERNATE INSULIN THERAPY UNTIL REPLACEMENT PUMP ARRIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858315 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00085006613373

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR