BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24627170 · Received March 18, 2026

    Report

    Report Number
    2245578-2026-00058
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 24, 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: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 22-APR-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 B26016B.

    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 (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A 40-YEAR-OLD FEMALE PATIENT WITH ABDOMINAL PAIN AND DIARRHEA. THERE WAS NO ADDITIONAL PATIENT INFORMATION. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. METHOD: DATE : COLLECTED TESTED: RESULT : SAMPLE POS/NEG: I-STAT, (B)(6) 0026 , 1443 , 1507 , >1000 NG/L , A, WB POS, I-STAT , (B)(6) 0026 , 1539 , 1557 , >1000 NG/L, A, WB POS, ATELLIC, (B)(6) 0026, 1912 , 1939 , 3 PG/ML, A WB NEG. 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
    370718 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B26016B

    Patients

    Seq Age Sex Outcome Treatment
    1