BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (HS-TNI ) CARTRIDGE

    MDR report key: 24059307 · Received January 13, 2026

    Report

    Report Number
    2245578-2026-00013
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 31, 2025
    Report Date
    March 12, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K240984
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 B25319A.

    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

    ON 06-JAN-2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT FALSE POSITIVE RESULTS ON A 55 -YEAR OLD FEMALE PATIENT WITH HISTORY OF CHF AND CARDIOMYOPATHY PRESENTS WITH CHEST PAIN AFTER DOING COCAINE. SERIAL EKGS SHOW T WAVE INVERSIONS WITHOUT ST ELEVATION OR DEPRESSION. THERE WAS NO ADDITIONAL PATIENT INFORMATION. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD: I-STAT; DATE: (B)(6) 2025; COLLECTED: 1:06; TESTED: 1:07; RESULTS(NG/L): >1000; SAMPLE: A: WB; POSITIVE/NEGATIVE: POSITIVE. METHOD: I-STAT; DATE: (B)(6) 2025; COLLECTED: 1:3; TESTED: 1:38; RESULTS(NG/L): >1000; SAMPLE: B: WB; POSITIVE/NEGATIVE: POSITIVE. METHOD: I-STAT; DATE: (B)(6) 2025; COLLECTED: 2:50; TESTED: 2:51; RESULTS(NG/L): >1000; SAMPLE: C: WB; POSITIVE/NEGATIVE: POSITIVE. METHOD: ALINITY; DATE: (B)(6) 2025; COLLECTED: 4:57; TESTED: 5:23; RESULTS(NG/L): 4; SAMPLE: D: PLASMA; POSITIVE/NEGATIVE: NEGATIVE. METHOD: ALINITY; DATE: (B)(6) 2025; COLLECTED: 9:29; TESTED: 10:14; RESULTS(NG/L): 3; SAMPLE: E: PLASMA; POSITIVE/NEGATIVE: NEGATIVE. 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: FEMALE; N: 490; (NG/L, PG/ML); 13; (NG/L, PG/ML): (10, 17). SEX: MALE; N: 404; (NG/L, PG/ML); 28; (NG/L, PG/ML): (19, 58). SEX: OVERALL; N: 895; (NG/L, PG/ML); 21; (NG/L, PG/ML): (14, 30).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161557 I-STAT TROPONIN (HS-TNI ) CARTRIDGE HS-TNI CARTRIDGE MMI ABBOTT POINT OF CARE INC. NA B25319A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other