BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 25111419 · Received May 7, 2026

    Report

    Report Number
    2245578-2026-00099
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 9, 2026
    Report Date
    May 7, 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
    CO, 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 48-YEAR-OLD FEMALE PATIENT WITH HISTORY OF FIBROIDS, ENDOMETRIOSIS, AND PRIOR GYNECOLOGIC SURGERIES PRESENTED WITH ABDOMINAL PAIN, CHEST TIGHTNESS, DIZZINESS, AND RECENT SHORTNESS OF BREATH. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: DATE : TESTED RESULTS: SAMPLE POSITIVE/NEGATIVE: I-STAT, (B)(6) 2026 , 19:00 >1000 NG/L , A , POSITIVE, COULTER, (B)(6) 2026, 23:26 <6 NG/L, B , NEGATIVE, COULTER, (B)(6) 2026, 02:30 <6 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
    433727 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B25314 00054749003051

    Patients

    Seq Age Sex Outcome Treatment
    1