BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT 6+ CARTRIDGE

    MDR report key: 886409 · Received July 30, 2007

    Report

    Report Number
    2245578-2007-00018
    Event Type
    Malfunction
    Date Received
    July 30, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 30, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 07/05/07, A DISTRIBUTOR NOTIFIED ABBOTT POINT OF CARE THAT A CUSTOMER HAD REPORTED THAT IN 2007, AN I-STAT 6+ CARTRIDGE YIELDED A HEMATOCRIT RESULT OF 16% PCV. ANOTHER SAMPLE FROM THIS PT WAS OBTAINED AND SENT TO A REFERENCE LABORATORY AND THE RESULT WAS 35.7% PCV. ONE DAY LATER, 007:24, THE PT'S HEMATOCRIT RESULT FROM A I-STAT 6+ CARTRIDGE WAS 36% PCV. NO TREATMENT WAS ADMINISTERED BASED ON THE I-STAT HEMATOCRIT RESULT OF 16 %PCV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT 6+ CARTRIDGE IVD JJE ABBOTT POINT OF CARE INC. NA A07050

    Patients

    Seq Age Sex Outcome Treatment
    1 YR