BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL DYN SAPPHIRE ANALYZER

    MDR report key: 828654 · Received October 25, 2006

    Report

    Report Number
    2919069-2006-00083
    Event Type
    Other
    Date Received
    October 25, 2006
    Date of Event
    September 27, 2006
    Report Date
    October 6, 2006
    Manufacturer
    ABBOTT LABORATORIES DIVISION/CELLDYN
    Product Code
    JPK
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED CUSTOMER SUPPORT STATING THAT AN INCORRECT HEMOGLOBIN RESULT OF 5.23 MMOL/L (8.48 G/DL) WAS GENERATED USING A CELL-DYN SAPPHIRE ANALYZER AND REPORTED TO A PHYSICIAN FOR ONE FEMALE PT (AGE AND WEIGHT WERE NOT PROVIDED). THE RESULT WAS SUBJECT TO DOUBT BECAUSE OF PREVIOUS HEMOGLOBIN RESULT HISTORY FOR THIS PT AND QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS THEN REPEATED USING THE SAME SAMPLE YIELDING A HEMOGLOBIN RESULT OF 7.19 MMOL/L (11.65 G/DL). ANOTHER SAMPLE OBTAINED FROM THIS PT WAS TESTED YIELDING A HEMOGLOBIN RESULT OF 7.2 MMOL/L (11.69). NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER JPK ABBOTT LABORATORIES DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR