BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24629939 · Received March 18, 2026

    Report

    Report Number
    2245578-2026-00059
    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 06-MAR-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE NEGATIVE 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 5.6 NG/L 7 NEGATIVE. ROCHE 42 NG/L NI POSITIVE. I-STAT 5.6 NG/L 8 NEGATIVE. ROCHE 38 NG/L NI POSITIVE. 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
    686211 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