BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12633346 · Received October 14, 2021

    Report

    Report Number
    3013756811-2021-111496
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 14, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TANDEM QUALITY ENGINEER REVIEWED PUMP DATA AND THERE IS NO EVIDENCE THAT THE PUMP EXPERIENCED A MALFUNCTION OR FAILURE. B5: REPLACE B5 STATEMENT. H6: REMOVE MEDICAL DEVICE - PROBLEM CODE 2582. B5: REPLACE B5 STATEMENT. H6: REMOVE MEDICAL DEVICE - PROBLEM CODE 2582.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL THAT WAS "LOW" PER CONTINUOUS GLUCOSE MONITOR READINGS, CAUSE WAS UNKNOWN. LOW BG WAS ADDRESSED BY CONSUMING CARBOHYDRATES. ADDITIONALLY, IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE CARTRIDGE TUBING. CUSTOMER PRIMED THE TUBING TO ADDRESS THE ISSUE. CUSTOMER'S BG LEVEL FOR THIS ISSUE WAS 212-217

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL THAT WAS "LOW" PER CONTINUOUS GLUCOSE MONITOR READINGS, CAUSE WAS UNKNOWN. LOW BG WAS ADDRESSED BY CONSUMING CARBOHYDRATES. ADDITIONALLY, IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED WITHIN THE CARTRIDGE TUBING. CUSTOMER PRIMED THE TUBING TO ADDRESS THE ISSUE. LASTLY, IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY. CUSTOMER'S BG LEVEL FOR THESE ISSUES WAS 212-217 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532897 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Other INSULIN: HUMALOG| INSULIN: HUMALOG