BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24119055 · Received January 20, 2026

    Report

    Report Number
    2245578-2026-00017
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    January 12, 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
    OH, 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 05-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 B25319.

    Description of Event or Problem · 0

    ON 15-JAN-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A 22 YEAR FEMALE PATIENT BACK & CHEST PAIN. THERE WAS NO ADDITIONAL INFORMATION. METHOD DATE, TESTED RESULTS (NG/L), SAMPLE POSITIVE/NEGATIVE: I-STAT (B)(6) 2026 , 19:30 >1000, A POSITIVE. I-STAT (B)(6) 2026, 19:55 >1000, B POSITIVE. POSITIVE CUT-OFF VALUE FOR I-STAT TROPONIN TEST: 13. FINAL PATIENT DIAGNOSIS: PRECORDIAL PAIN. 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
    55244 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B25319

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female