BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24247120 · Received February 3, 2026

    Report

    Report Number
    2245578-2026-00024
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 25, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K240984
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: (B)(4). THE INVESTIGATION WAS COMPLETED ON 18-MAR-2026. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE CARTRIDGE LOT MET FINISHED GOODS RELEASE CRITERIA. 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 B25338C.

    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 01/30/-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A 62 YEAR OLD FEMALE PATIENT PRESENTED WITH DIZZINESS, ELEVATED TROPONINS, & ATYPICAL CHEST PAIN. THERE WAS NO ADDITIONAL PATIENT INFORMATION. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD DATE COLLECTED TESTED RESULTS (NG/L) SAMPLE POSITIVE/NEGATIVE I-STAT (B)(6) 2026 17:39 17:39 87 A POSITIVE. I-STAT (B)(6) 2026 19:54 19:54 103 B POSITIVE. ALINITY (B)(6) 2026 1:12 1:12 <3 C NEGATIVE. ALINITY (B)(6) 2026 3:23 3:23 <3 D NEGATIVE. POSITIVE CUT-OFF VALUE FOR I-STAT HS-TNI TEST: >13 NG/L POSITIVE CUT-OFF VALUE FOR COMPARATIVE INSTRUMENT: >14 PG/ML. 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
    172623 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B25338C

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female