BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 24541617 · Received March 7, 2026

    Report

    Report Number
    2245578-2026-00046
    Event Type
    Malfunction
    Date Received
    March 7, 2026
    Date of Event
    January 5, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 17-FEB-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 73-YEAR-OLD MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. DATE: TESTED: RESULT: HEPARIN: HEPARIN TIME: ON (B)(6) 2026, 20000, 8:26, ON (B)(6) 2026, 8:38, 322, ON (B)(6) 2026, 3000, 8:40, ON (B)(6) 2026, 8:51, 332, ON (B)(6) 2026, 4000, 8:52, ON (B)(6) 2026, 9:04, 332, ON (B)(6) 2026, 4000, 9:08, ON (B)(6) 2026, 9:19, 353, ON (B)(6) 2026, 2000, 9:23, ON (B)(6) 2026, 9:36, 363, ON (B)(6) 2026, 10:05, 173, ON (B)(6) 2026, 10:21, 414, ON (B)(6) 2026, 10:43, 378, ON (B)(6) 2026, 11:02, 373, ON (B)(6) 2026, 11:37, 194. 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
    43344 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R25277

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male