BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 25111421 · Received May 7, 2026

    Report

    Report Number
    2245578-2026-00097
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    UDI-DI
    00054749003051
    PMA / PMN Number
    K240984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 21-APR-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULT ON A 70-YEAR-OLD FEMALE PATIENT WITH BURNING PAIN TO THE ENTIRE BACK THEN BOTH ARMS. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: TESTED: RESULTS: SAMPLE: POSITIVE/NEGATIVE: I-STAT, ON (B)(6) 2026, 19:00 >1000 NG/L, A, POSITIVE, ROCHE, ON (B)(6) 2026, 23:26 <6 NG/L, B, NEGATIVE, ROCHE, ON (B)(6) 2026, 02:30 <6 NG/L, C, NEGATIVE. 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
    433729 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B26028 00054749003051

    Patients

    Seq Age Sex Outcome Treatment
    1