BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 1700

    MDR report key: 680337 · Received February 23, 2006

    Report

    Report Number
    2919069-2006-00012
    Event Type
    Other
    Date Received
    February 23, 2006
    Date of Event
    January 29, 2006
    Report Date
    January 29, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    JPK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER TECHNICAL ADOVCATE (CTA) WAS CONTACTED WITH REGARD TO A LOW HEMOGLOBIN RESULT GENERATED WHEN USING A CELL-DYN 1700 ANALYZER. IN 2006 A PATIENT WITH A HGB=5.0 G/DL WAS TRANSFUSED WITH 3 UNITS OF BLOOD. THE FOLLOWING DAY A HGB=7.9 G/DL WAS OBTAINED. THE FOLLOWING DAY A NEW SAMPLE WAS DRAWN AND A HGB=6.1 G/DL WAS OBTAINED WHICH WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT WAS REDRAWN AND A SAMPLE SENT OT A REFERENCE LAB OBTAINING DUPLICATE RESULTS OF HGB=9.0 G/DL. 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 39 YR