BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 25301997 · Received May 27, 2026

    Report

    Report Number
    2245578-2026-00118
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 27, 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
    IN, 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 20-MAY-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULT ON A PATIENT. THERE WAS NO PATIENT INFORMATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS SAMPLE POSITIVE/NEGATIVE I-STAT (B)(6) 2026 10:32 11:48 797.9 NG/L A POSITIVE VITROS (B)(6) 2026 10:32 14:44 <2.25 NG/L A NEGATIVE I-STAT (B)(6) 2026 10:32 14:44 106.7 NG/L A POSITIVE I-STAT (B)(6) 2026 13:40 14:48 20.5 NG/L B NEGATIVE I-STAT (B)(6) 2026 13:40 15:00 44.4 NG/L B POSITIVE VITROS (B)(6) 2026 13:40 15:00 <2.25 NG/L B NEGATIVE I-STAT (B)(6) 2026 15:55 16:00 39.5 NG/L C POSITIVE VITROS (B)(6) 2026 15:55 16:00 <2.25 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
    528312 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B25310 00054749003051

    Patients

    Seq Age Sex Outcome Treatment
    1