BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14799181 · Received June 24, 2022

    Report

    Report Number
    3013756811-2022-66060
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 1, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY AFTER THE CUSTOMER SHOWERED WITH THE PUMP ON. UPON TURNING THE PUMP BACK ON, A MALFUNCTION ALARM OCCURRED. REPORTEDLY THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 250-255 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256763 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female