BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24118854 · Received January 20, 2026

    Report

    Report Number
    2245578-2026-00016
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 11, 2026
    Report Date
    March 12, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K240984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 03-MAR-2026. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. RETAINED AND RETURNED 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 B25304.

    Description of Event or Problem · 0

    ON 12-JAN-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A 51 YEAR FEMALE PATIENT PRESENTED WITH CHEST PAIN (CHEST SWELLING), CHEST CELLULITIS, STERNAL OSTEOMYELITIS. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE TESTED RESULTS (SEC) SAMPLE POSITIVE/NEGATIVE I-STAT (B)(6) 2026 15:24 >1000 A POSITIVE BECKMAN (B)(6) 2026 15:42 4 A NEGATIVE I-STAT (B)(6) 2026 17:22 >1000 B POSITIVE BECKMAN (B)(6) 2026 17:45 3 B NEGATIVE POSITIVE CUT-OFF VALUE FOR I-STAT TROPONIN TEST: 13 POSITIVE CUT-OFF VALUE FOR COMPARATIVE INSTRUMENT: EQUAL TO AND LESS THAN 12 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
    54032 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B25304

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female