BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17190848 · Received June 23, 2023

    Report

    Report Number
    3013756811-2023-87123
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    June 2, 2023
    Report Date
    July 14, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. PER TANDEM¿S T:SLIM X2 WITH CONTROL-IQ USER GUIDE: "YOUR PUMP IS WATERTIGHT TO A DEPTH OF 3 FEET (0.91 METERS) FOR UP TO 30 MINUTES (IPX7 RATING), BUT IT IS NOT WATERPROOF. YOUR PUMP SHOULD NOT BE WORN WHILE SWIMMING, SCUBA DIVING, SURFING, OR DURING ANY OTHER ACTIVITIES THAT COULD SUBMERGE THE PUMP FOR AN EXTENDED PERIOD OF TIME." H3: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER WAS SWIMMING WITH THE PUMP PRIOR TO MALF OCCURRING. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED 150-171 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222511 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female