BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 12263736 · Received August 2, 2021

    Report

    Report Number
    3013756811-2021-81860
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 2, 2021
    Report Date
    August 2, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. PER THE TANDEM USER GUIDE: 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. YOUR PUMP SHOULD NOT BE WORN IN HOT TUBS OR JACUZZIS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. REPORTEDLY, THE PUMP WAS EXPOSED TO WATER. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 110-148 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155041 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR