BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 2050625 · Received March 15, 2011

    Report

    Report Number
    2245578-2011-00039
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    December 22, 2010
    Report Date
    March 15, 2011
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. APOC PRODUCT ACTION NUMBER: (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. ABBOTT POINT OF CARE INC HAS DETERMINED, THROUGH INTERNAL REVIEW, THAT I-STAT EG7+ CARTRIDGE LOT S10246A MAY GENERATE FALSELY DEPRESSED PCO2 RESULTS FOR SAMPLES ABOVE 26 MMHG WHEN STORED AT ROOM TEMPERATURE FOR FOUR WEEKS OR LONGER. INTERNAL STUDIES HAVE SHOWN THAT THE INDIVIDUAL DATA POINTS ASSOCIATED WITH THIS CARTRIDGE LOT MAY READ MORE THAN 15 MMHG LOW. THIS ISSUE IS SPECIFIC TO REPORTED PCO2 VALUES; NO OTHER ANALYTES ARE AFFECTED. THIS ACTION IS BEING CONDUCTED IN COOPERATION WITH THE UNITED STATES FOOD AND DRUG ADMINISTRATION AND HEALTH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE CHL ABBOTT POINT OF CARE S10246A

    Patients

    Seq Age Sex Outcome Treatment
    1