BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24059296 · Received January 13, 2026

    Report

    Report Number
    2245578-2026-00015
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 2, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K240984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 24-FEB-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 A25265C. 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 08-JAN-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A PATIENT. THERE WAS NO PATIENT INFORMATION. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT, TESTED: 1324, RESULT: 132.8. METHOD: BECKMAN DXI, TESTED: -, RESULT: 14. METHOD: I-STAT, TESTED: 1525, RESULT: 142.7. METHOD: BECKMAN DXI, TESTED: -, RESULT: 15. METHOD: I-STAT, TESTED: 1525, RESULT: 143.2. METHOD: I-STAT, TESTED: 1525, RESULT: 144.7. 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: FEMALE, N: 490, (NG/L, PG/ML): 13, (NG/L, PG/ML): (10, 17). SEX: MALE, N: 404, (NG/L, PG/ML): 28, (NG/L, PG/ML): (19, 58). SEX: OVERALL, N: 895, (NG/L, PG/ML): 21, (NG/L, PG/ML): (14, 30).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121670 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA A25265C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown