BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 25226215 · Received May 20, 2026

    Report

    Report Number
    2245578-2026-00111
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 20, 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
    WI, 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 07-MAY-2026, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULTS ON A 65 YEAR OLD FEMALE PATIENT WITH AFIB. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: TESTED: RESULTS: HEPARIN: TIME: 7500UNITS 10:40 (B)(6) 2026 100:56:12 245SEC; 4000UNITS 10:58 (B)(6) 2026 11:16:54 286SEC; 4000UNITS 11:26 (B)(6) 2026 11:30:21 >1000SEC; (B)(6) 2026 11:31:18 307SEC; (B)(6) 2026 11:54:07 394SEC; (B)(6) 2026 12:43:13 342SEC; 4000UNITS 12:48 (B)(6) 2026 13:23:36 353SEC; 2000UNITS 13:25; 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
    197830 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R26100A 10054749000156

    Patients

    Seq Age Sex Outcome Treatment
    1