BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACT KAOLIN CARTRIDGE

    MDR report key: 21467958 · Received February 26, 2025

    Report

    Report Number
    2245578-2025-00022
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    February 17, 2024
    Report Date
    April 15, 2025
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K023582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 (B)(6) 2025. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THE CARTRIDGE LOT PASSED RELEASE SPECIFICATIONS. RETAINED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). DUE TO THE SMALL SAMPLE SIZE FOR RETURNED CARTRIDGES, ALLOWABLE ERROR (EA) ACCEPTANCE CRITERION COULD NOT BE ASSESSED. THERE ARE NO MINIMUM SAMPLE SIZE REQUIREMENTS FOR ASSESSING THE ACCEPTANCE CRITERION FOR RATE OF SUPPRESSED RESULTS. RETURNED CARTRIDGE TESTING MET THE ACCEPTANCE CRITERIA FOR SUPPRESSED RESULTS IN APPENDIX 1 OF Q04.01.003 REV. AN (PRODUCT COMPLAINT LEVEL 2 AND LEVEL 3 INVESTIGATION PROCEDURE). THE CUSTOMER'S OBSERVATION OF UNEXPECTED RESULTS WAS NOT REPRODUCED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT KAOLIN CARTRIDGES THAT YIELDED A DISCREPANT RESULT OF 95 SECONDS ON A 79-YEAR-OLD MALE WITH PERIPHERAL ARTERY DISEASE. THE PATIENT WAS PRESENTED WITH LEG PAIN AND HYPERLIPIDEMIA. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. DATE: COLLECTED TESTED: RESULTS HEPARIN, DOSE HEPARIN: TIME: ON (B)(6)2024, 8000 , 12:53. ON (B)(6) 2024, 12:02 , 12:03 , 95, ON (B)(6) 2024, 12:07 , 12:08 , 124, 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
    703762 I-STAT ACT KAOLIN CARTRIDGE ACT KAOLIN CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA R25009

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female