BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24956315 · Received April 22, 2026

    Report

    Report Number
    2245578-2026-00095
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    February 21, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    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 (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 60-YEAR-OLD FEMALE PATIENT THAT PASSED OUT, BECAME SYNCOPE AND HAD A HEAD INJURY. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULT SAMPLE POS/NEG I-STAT (B)(6) 2026 1311 1330 900 NG/L WB-VEN #1 POS. I-STAT (B)(6) 2026 1543 1605 >1000 NG/L WB-VEN #2 POS. LAB (B)(6) 2026 2120 2147 4 PLASMA NEG. LAB (B)(6) 2026 0342 0425 5 PLASMA NEG FACILITY POSITIVE CUT-OFF: I-STAT- NI BECKMAN: POSITIVE CUT OFF VALUE 0-12 (FEMALE) MALE (0-20). 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
    408669 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B26033

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female