BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM DIABETES 3ML LL WITH CO-PACKED NEEDLE 26GX3/8"KDL

    MDR report key: 23418518 · Received October 29, 2025

    Report

    Report Number
    1035907-2025-00037
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    July 19, 2025
    Report Date
    February 11, 2026
    Manufacturer
    EXELINT INTERNATIONA, CO
    Product Code
    FMF
    UDI-DI
    00020221261158
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE ISSUE THAT INCLUDED THE FOLLOWING: RETAINED SAMPLES WERE EXAMINED THAT INCLUDED THE FOLLOWING: FIVE RANDOMLY RETAINED SAMPLES WERE SELECTED FROM THIS SPECIFIC BATCH FOR SIMULATED ASPIRATION AND INJECTION TESTS. NO ISSUES WITH ASPIRATION AND INJECTION WERE FOUND. ADDITIONALLY, A REVIEW OF THE PRODUCTION PROCESS, FINISHED PRODUCT INSPECTION, AND INCOMING INSPECTION F THE INJECTION NEEDLES WERE CONDUCTED, AND NO ABNORMALITIES WERE IDENTIFIED IN THE INJECTION NEEDLES. PRODUCT RECORDS - THE RECORDS RELATED TO PRODUCT 1001215 LOT 240508, PRODUCT RECORDS AND INSPECTION REPORT WERE REVIEWED. ALL DOCUMENTS WERE FOUND TO BE ACCEPTABLE, AND NO NONCONFORMITIES. BASED ON THE INVESTIGATION, THE REPORTED ISSUE COULD NOT BE REPRODUCED. NO DEFECTS OR ABNORMALITIES WERE FOUND IN THE RETAINED SAMPLES, AND NO NONCONFORMITIES WERE IDENTIFIED. (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    CALLER REPORTED THEY COULD NOT DRAW AIR IN OR OUT OF THE SYRINGE. WHILE TRYING TO DO SO CUSTOMER ACCIDENTALLY STABBED THEIR FINGER WITH THE NEED AND INJECTED AIR INTO THEMSELVES. CUSTOMER WENT TO THE ER AND DOCTOR DID NOT HAVE TO TAKE ANY ACTION UPON OBSERVATION. NO SUBSTANTIAL DAMAGE OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2685819 TANDEM DIABETES 3ML LL WITH CO-PACKED NEEDLE 26GX3/8"KDL SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONA, CO 1001215 240508 00020221261158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization