BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 12843432 · Received November 19, 2021

    Report

    Report Number
    3013756811-2021-129123
    Event Type
    Malfunction
    Date Received
    November 19, 2021
    Date of Event
    November 9, 2021
    Report Date
    November 19, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR WAS SUBMITTED IN ERROR. ALLEGED ISSUE DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY AND DOES NOT HAVE THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY. THIS EVENT DOES NOT MEET MDR REQUIREMENTS AS DEFINED BY 21 CFR 803. H6: REMOVE CODES 1503, 67, 4114, 3221, 2199, AND 4582. INITIAL MDR WAS SUBMITTED IN ERROR. ALLEGED ISSUE DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY AND DOES NOT HAVE THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY. THIS EVENT DOES NOT MEET MDR REQUIREMENTS AS DEFINED BY 21 CFR 803. H6: REMOVE CODES 1503, 67, 4114, 3221, 2199, AND 4582.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. REPORTEDLY, CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 100 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742851 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male