BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 25226216 · Received May 20, 2026

    Report

    Report Number
    2245578-2026-00116
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 8, 2026
    Report Date
    May 20, 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
    TX, 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 12-MAY-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULT ON A 35 YEAR OLD FEMALE WITH ANXIETY. THERE WAS NO ADDITIONAL PATIENT INFORMATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: COLLECTED: TESTED: RESULT: SAMPLE: POSITIVE/NEGATIVE :I-STAT (B)(6) 2026 1155 1157 20 NG/L WB POSITIVE; ALINITY (B)(6) 2026 1201 1249 12 NG/L PLASMA NEGATIVE; I-STAT (B)(6) 2026 1340 1400 20.2 NG/L WB POSITIVE; ALINITY (B)(6) 2026 1340 1431 11 NG/L PLASMA 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
    197831 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B26066 00054749003051

    Patients

    Seq Age Sex Outcome Treatment
    1