BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 24629910 · Received March 18, 2026

    Report

    Report Number
    2245578-2026-00064
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 18, 2026
    Report Date
    March 8, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    UDI-DI
    10054749000156
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Description of Event or Problem · 0

    ON 09-MAR-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 78-YEAR-OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE TESTED RESUT (B)(6) 2026 1543 481 SEC. (B)(6) 2026 1611 808 SEC. (B)(6) 2026 1635 532 SEC. (B)(6) 2026 1704 424 SEC. (B)(6) 2026 1732 450 SEC. (B)(6) 2026 1800 122 SEC. (B)(6) 2026 1836 747 SEC. (B)(6) 2026 1847 460 SEC. (B)(6) 2026 1908 445 SEC. (B)(6) 2026 1926 429 SEC. (B)(6) 2026 1954 137 SEC. AT THIS TIME THERE IS NO REASON TO SUSPECT A MALFUNCTION EXISTS. THE REPORTING DECISION WAS BASED ON THE LIMITED INFORMATION AVAILABLE THAT SUGGESTS THE PRODUCT WAS NOT PERFORMING WITHIN THE VARIABILITY OF THE ASSAY. AN INVESTIGATION IS UNDERWAY. PER I-STAT SYSTEM MANUAL (ART: 714185-00Q), THE I-STAT KAOLIN ACTIVATED CLOTTING TIME (KAOLIN ACT) TEST IS AN IN VITRO DIAGNOSTIC TEST THAT USES FRESH, WHOLE BLOOD. AND IS USED TO MONITOR HIGH-DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692007 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R25319A 10054749000156

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female