BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24434361 · Received February 24, 2026

    Report

    Report Number
    2245578-2026-00045
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 18, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K240984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: (B)(4). THE INVESTIGATION WAS COMPLETED ON 12-MAR-2026. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS (FG) RELEASE CRITERIA. A DEFICIENCY HAS BEEN IDENTIFIED FOR HS-TNI CARTRIDGE LOT A25210B. WHILE RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOR THE DETECTED ERROR (DT) AND UNDETECTED ERROR (UDT) RATES OUTLINED IN APPENDIX 1 OF Q04.01.003 REV. AP (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE), THE FG RELEASE SPECIFICATION FOR STANDARD DEVIATION (SD) PER TP-0651 REV. BI (CARTRIDGE FINISHED GOODS TEST SPECIFICATION) WAS NOT MET. ROOT CAUSE WILL BE INVESTIGATED IN QUALITY RECORD (QR) 1100932.

    Description of Event or Problem · 0

    ON 19-FEB-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A 46 YEAR OLD MALE PATIENT WITH CHEST PAIN & SUBACUTE COUGH. THERE WAS NO ADDITIONAL PATIENT INFORMATION. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED RESULT SAMPLE POSITIVE/NEGATIVE I-STAT (B)(6) 2026 14:47 976 A POSITIVE ROCHE (B)(6) 2026 14:47 11 A NEGATIVE I-STAT (B)(6) 2026 16:44 635 B POSITIVE ROCHE (B)(6) 2026 16:44 7 B NEGATIVE I-STAT (B)(6) 2026 17:37 590 C POSITIVE ROCHE (B)(6) 2026 17:37 9 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).

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3179 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA A25210B

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male