BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 24367737 · Received February 17, 2026

    Report

    Report Number
    2245578-2026-00035
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 22, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Additional Manufacturer Narrative · 0

    APOC INCIDENT: # (B)(4). THE INVESTIGATION WAS COMPLETED ON 13-APR-2026. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) CONFIRMED THE CARTRIDGE LOTS PASSED RELEASE SPECIFICATIONS. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA IN APPENDIX 1 OF Q04.01.003 REV. AP (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). NO DEFICIENCY HAS BEEN IDENTIFIED.

    Description of Event or Problem · 0

    ON 06-FEB-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 FEMALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. DATE TESTED RESULT HEP-DOSE HEP-TIME (B)(6) 2026 07:58 138 (B)(6) 2026 26,000 10:07 (B)(6) 2026 10:20 419 (B)(6) 2026 10,000 10:21 (B)(6) 2026 10:37 506 (B)(6) 2026 11:19 >1000 (B)(6) 2026 11:31 675 (B)(6) 2026 11:58 650 (B)(6) 2026 12:51 133 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: (B)(4), 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.

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430998 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