BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 15052301 · Received July 19, 2022

    Report

    Report Number
    3013756811-2022-72573
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    June 26, 2022
    Report Date
    June 26, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00085006613373
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE ALLEGED ISSUE UNEXPECTED RESET WAS VERIFIED IN THE PUMP LOGS; HOWEVER, NO FAILURE WAS IDENTIFIED. BASED ON THE ANALYSIS, THE ALLEGED PUMP TIME ISSUE COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP RESET UNEXPECTEDLY. SUBSEQUENTLY AFTER THE PUMP RESET, THE PUMP TIME BECAME INACCURATE. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 200-249 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261289 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 63 YR Female