BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 11087840 · Received December 29, 2020

    Report

    Report Number
    3013756811-2020-149759
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 14, 2020
    Report Date
    December 29, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WAS SUBMITTED IN ERROR. ALLEGED ISSUE DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY. THIS EVENT DOES NOT MEET MDR REQUIREMENTS AS DEFINED BY 21 CFR 803.

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN ON BOARD (IOB) READINGS WERE INACCURATE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 122-124 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1551665 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR