BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24872879 · Received April 14, 2026

    Report

    Report Number
    2245578-2026-00093
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 30, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K240984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # (B)(4). APOC LABELING WILL BE EVALUATED DURING THE INVESTIGATION AS PERTAINING TO THE EVENT.

    Description of Event or Problem · 0

    ON 07-APR-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULT ON A 27-YEAR-OLD MALE PATIENT WITH CHEST PAIN. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED RESULT POS/NEG ALINITY (B)(6) 2026 1815 14 NEG I-STAT (B)(6) 2026 1834 31.5 POS ALINITY (B)(6) 2026 1925 15 NEG I-STAT (B)(6) 2026 1944 29.9 POS FACILITY POSITIVE CUT-OFF: I-STAT- 21. ALINITY <=27 NG/L. THERE ARE NO INJURIES ASSOCIATED WITH THIS EVENT. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE INVESTIGATION IS UNDERWAY. 99TH PERCENTILE 90% CI SEX N (NG/L, PG/ML) (NG/L, PG/ML). FEMALE 490 13 (10, 17). MALE 404 28 (19, 58). OVERALL 895 21 (14, 30).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159759 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA C26012A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Male