BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CELITE ACT CARTRIDGE

    MDR report key: 1920737 · Received December 6, 2010

    Report

    Report Number
    2245578-2010-00159
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 12, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PART/LIST NUMBER: 07G01-02, 600-9006-25, 03P86-25. LOT NUMBER(S): ALL. DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. 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. ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THAT ALTHOUGH THE I-STAT CELITE CARTRIDGE AND TEST INFO (CTI) SHEET CURRENT INDICATES THAT CARTRIDGES CAN BE STORED FOR TWO WEEKS AT ROOM TEMPERATURE, APOC HAS DETERMINED, THROUGH INTERNAL STUDIES, THAT THE I-STAT CELITE CARTRIDGES MAY EXHIBIT A HIGHER THAN EXPECTED VARIABILITY IN REPORTED RESULTS WHEN STORED AT ROOM TEMPERATURE FOR PERIODS OF TIME IN EXCESS OF 12 HOURS. THERE IS NO IMPACT TO REPORTED RESULTS WHEN CARTRIDGES ARE STORED REFRIGERATED AND WARMED TO ROOM TEMPERATURE FOR USE WITHIN 12 HOURS. THIS ACTION IS BEING CONDUCTED IN COOPERATION 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 CELITE ACT CARTRIDGE ACT C CARTRIDGE JJE ABBOTT POINT OF CARE SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1