BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T SLIM INSULIN PUMP

    MDR report key: 14193696 · Received April 22, 2022

    Report

    Report Number
    MW5109285
    Event Type
    Injury
    Date Received
    April 22, 2022
    Report Date
    April 20, 2022
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QJI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT USES TANDEM PUMP WITH CONTROL IQ. PATIENT HAS REPORTED MANY INSTANCES OF SIGNAL LOSS DESPITE WEARING PUMP AND CGM ADEQUATELY. HE RECENTLY ALSO REPORTED ENTERING CARBS INTO HIS PUMP CORRECTLY, BUT THEN NOTICING THE PUMP ENTERED HUNDREDS OF CARBS INSTEAD OF THE AMOUNT HE ENTERED. DID NOT HAVE HYPOGLYCEMIA DURING THIS SECOND EPISODE DUE TO ONGOING FOOD INTAKE. PATIENT REPORTS CONTACTING TANDEM EVERY TIME AN ISSUE OCCURS, IS OFTEN SENT A NEW TRANSMITTER, BUT PROBLEMS CONTINUE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841351 TANDEM T SLIM INSULIN PUMP INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER QJI TANDEM DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention