BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT KAOLIN ACT AND CELITE ACT CARTRIDGE

    MDR report key: 1868721 · Received October 7, 2010

    Report

    Report Number
    2245578-2010-00125
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NAME: I-STAT CELITE ACT CARTRIDGES: PART/LIST NUMBER(S): 07G01-02, 600-9006-25. LOT#S: S10136A, S10150A, S10151, S10155. PRODUCT NAME: I-STAT KAOLIN ACT CARTRIDGES PART/LIST NUMBER: 07G81-01, 07G81-02, LOT NUMBER(S): S10128A, S10128B, S10128C, S10129, S10129A, S10130, S10130B, S10147A, S10147B, S10147C, S10147D, S10147E, S10148A, S10148B, S10148C, S10148D, S10148G, S10149, S10149B, S10149C, S10151A, S10151B, S10152, S10152A, S10152B, S10152C, S10152D, S10152E, S10152F, S10154A, S10154B, S10154D, S10160B, S10162. DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN CO-OPERATION WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION. (B)(4).

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. THE I-STAT CELITE ACTIVATED CLOTTING TIME TEST (CELITE ACT) IS USED FOR MONITORING MODERATE- AND HIGH-LEVEL HEPARIN THERAPY. THE I-STAT KAOLIN ACTIVATED CLOTTING TIME TEST (KAOLIN ACT) IS USED TO MONITOR HIGH DOSE HEPARIN ANTICOAGULATION FREQUENTLY ASSOCIATED WITH CARDIOVASCULAR SURGERY. ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THAT CERTAIN LOTS OF I-STAT CELITE ACT AND KAOLIN ACT CARTRIDGES MAY BE DIFFICULT TO FILL OR WILL NOT FILL WHEN ATTEMPTING TO TRANSFER BLOOD TO THE SAMPLE ENTRY PORT OF THE CARTRIDGE, FOLLOWING THE PROCEDURE (ART (B)(4)). RESULTS, WHEN GENERATED, ARE WITHIN THE EXPECTED PERFORMANCE OF THE ASSAYS. ABBOTT POINT OF CARE HAS MADE THE DECISION TO REMOVE THESE CARTRIDGE LOTS FROM THE MARKETPLACE TO ENSURE THE PERFORMANCE OF OUR PRODUCT. THIS ACTION IS BEING CONDUCTED IN CO-OPERATION WITH THE U.S FOOD AND DRUG ADMINISTRATION AND HEALTH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT KAOLIN ACT AND CELITE ACT CARTRIDGE ACT K AND C CARTRIDGE JBP ABBOTT POINT OF CARE S10127B

    Patients

    Seq Age Sex Outcome Treatment
    1