BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 23980897 · Received January 6, 2026

    Report

    Report Number
    2245578-2026-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 15, 2025
    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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT # 995006. 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-2024. 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 A25227. 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) (B)(4).

    Description of Event or Problem · 0

    ON 18-DEC-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A 79 YEAR OLD MALE PATIENT WITH ABDOMINAL PAIN, UNSPECIFIED. THERE WAS NO PATIENT INFORMATION, NO DETAILS SURROUNDING THE EVENT. CARTRIDGE LOT# INFORMATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. METHOD DATE COLLECTED TESTED RESULT SAMPLE POSITIVE/NEGATIVE I-STAT (B)(6) 2025 1644 1704 >1000 A-WB POSITIVE ATELLICA (B)(6) 2025 1821 1920 13 B-PLASMA NEGATIVE I-STAT 12(B)(6) 2025 1836 12/17/251820 >1000 C-WB POSITIVE ATELLICA (B)(6) 2025 2254 2328 15 D-PLASMA POSITIVE 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
    42180 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA A25227

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male