BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 15112843 · Received July 27, 2022

    Report

    Report Number
    3013756811-2022-78162
    Event Type
    Malfunction
    Date Received
    July 27, 2022
    Date of Event
    July 7, 2022
    Report Date
    October 26, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, THE DISTRIBUTOR REPORTED THE ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. PER TANDEM'S USER GUIDE: YOUR T:SLIM X2 PUMP IS WATERTIGHT TO A DEPTH OF 3 FEET FOR UP TO 30 MINUTES (IPX7 RATING), BUT IT IS NOT WATERPROOF. B5, H6 (REMOVE: 1503, 67). B5, H6 (REMOVE: 1503, 67).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS XX MG/DL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP FELL INTO A POOL AND SUBSEQUENTLY STOPPED WORKING. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2033173 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 Unknown INSULIN: HUMALOG.