BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 680355 · Received February 23, 2006

    Report

    Report Number
    2919069-2006-00011
    Event Type
    Other
    Date Received
    February 23, 2006
    Date of Event
    January 20, 2006
    Report Date
    February 3, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    JPK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER TECHNICAL ADVOCATE (CTA) WAS CONTACTED WITH REGARD TO HEMOGLOBIN AND HEMATOCRIT (H&H) RESULT NOT MATCHING FOR PATIENTS WHEN USING A CELL-DYN 1700 ANALYZER. ALL QC WAS IN RANGE. A NURSE PRACTITIONER QUESTIONED THE RESULTS FOR ONE PATIENT. THE ACCOUNT PROVIDED THE HEMOGLOBIN RESULTS FOR THIS PATIENT. AN INITIAL HGB=8.5 G/DL WAS OBTAINED AND A REPEAT YIELDED A HGB=10.5 G/DL RESULT. THREE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL PATIENT INFORMATION/DATA BUT NONE WAS PROVIDED. THE ACCOUNT MENTIONED THAT H&H MISMATCHES WERE ONLY OCCURRING WITH ONE OPERATOR OF THE CELL-DYN 1700 ANALYZER. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1700 AUTOMATED HEMATOLOGY ANALYZER JPK ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN