BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24627174 · Received March 18, 2026

    Report

    Report Number
    2245578-2026-00063
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 18, 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
    CA, 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 (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULT ON A MALE PATIENT. THERE WAS NO PATIENT INFORMATION, NO DETAILS SURROUNDING THE EVENT. THERE WERE MULTIPLE REQUESTS FOR INFORMATION BUT TO NO AVAIL. METHOD: RESULTS: SAMPLE POSITIVE/NEGATIVE: I-STAT , 29.9 NG/L , A POSITIVE, LAB , 16 NG/L , NI NEGATIVE. FACILITY POSITIVE CUT-OFF: I-STAT MALE 99TH%: 28.0 NG/L, I-STAT FEMALE 99TH%: 13.0 NG/L, ROCHE MALE 99TH%: 22.0 NG/L, ROCHE FEMALE 99TH%: 14.0 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
    688626 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 NA Male