BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 25159195 · Received May 13, 2026

    Report

    Report Number
    2245578-2026-00103
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 13, 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
    UK
    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 57 YEAR OLD PATIENT. THERE WAS NO PATIENT INFORMATION, NO DETAILS SURROUNDING THE EVENT.. THERE WERE MULTIPLE REQUESTS FOR INFORMATION BUT TO NO AVAIL. METHOD: RESULT: SAMPLE: I-STAT, >1000 NG/L, WB A; I-STAT, >1000 NG/L, PLASMA A; I-STAT, >1000 NG/L, PLASMA A; LAB, 6 NG/L, PLASMA A; I-STAT, >1000 NG/L, PLASMA B; LAB, 5 NG/L, PLASMA B; LAB, 6 NG/L, PLASMA C; LAB, 6 NG/L, PLASMA D; I-STAT, 31.4 NG/L, WB E; I-STAT, 21.3 NG/L, PLASMA E; LAB, <4 NG/L, PLASMA E; I-STAT, 5.2 NG/L, PLASMA F; LAB, <4 NG/L, PLASMA F; NO TEST/COLECTION TIMES OR DATES PROVIDED. 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
    75979 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA NI 00054749003051

    Patients

    Seq Age Sex Outcome Treatment
    1