BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24752699 · Received April 1, 2026

    Report

    Report Number
    2245578-2026-00078
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    December 22, 2025
    Report Date
    April 17, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K240984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 14-APR-2026. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. ALTHOUGH RETAINED CARTRIDGES COULD NOT BE TESTED AS THE LOT EXPIRED ON 31-DEC-2025, PREVIOUS RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AP (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED FOR HS-TNI CARTRIDGE LOT A25114.

    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

    NA.

    Description of Event or Problem · 0

    ON 20-MAR-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULT ON A 41-YEAR-OLD MALE PATIENT WITH SHOULDER PAIN AFTER GETTING STRUCK BY CAR GOING 25PH. THERE WAS NO ADDITIONAL PATIENT INFORMATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE: COLLECTED: TESTED: RESULTS: SAMPLE: POS/NEG: COBAS, ON (B)(6) 2025, 1418, 2003, 12, ART, NEG, I-STAT, ON (B)(6) 2025, NI, 1959, 139, ART, POS, COBAS, ON (B)(6) 2025, 2014, 2023, 15, ART, NEG. FACILITY POSITIVE CUT-OFF: I-STAT TROPONIN TEST: 21. COBAS MALE >=22 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
    545826 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA A25114

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male