BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 24697519 · Received March 26, 2026

    Report

    Report Number
    2245578-2026-00075
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 2, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 (B)(6) 2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 77-YEAR-OLD CORONARY ARTERY DISEASE FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE: TESTED RESULTS(SEC): HEPARIN DOSE: HEPARIN TIME: (B)(6) 2026 , 6000, 08:12, (B)(6) 2026, 08:26, 158, (B)(6) 2026, 4000 , 08:27. (B)(6) 2026 , 08:41, 112, (B)(6) 2026 , 08:48 , 117, (B)(6) 2026 ,09:01, 153, (B)(6) 2026 , 09:02 , 163, (B)(6) 2026 , 09:25 , 307, 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
    596483 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R25309

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female