BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF ANALYZER

    MDR report key: 1887063 · Received November 1, 2010

    Report

    Report Number
    1061932-2010-00191
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    September 14, 2010
    Report Date
    November 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN 4ML BD TUBE AND PROCESSED IN WHOLE BLOOD MODE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010 AND ADJUSTED THE MCV.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING HIGH MEAN CELL VOLUME (MCV) AND RED CELL DISTRIBUTION WIDTH (RDW) RESULTS WITHOUT INSTRUMENT FLAGS THAT WERE GENERATED BY THE COULTER AC*T DIFF ANALYZER. PER THE CUSTOMER, THE PHYSICIAN QUESTIONED THE RESULTS FOR ONE OF THE SIX SAMPLES PROVIDED WITH THIS CASE AND SENT THE SPECIMEN TO A REFERENCE LAB FOR RERUN. THE RERUN SPECIMEN RECOVERED LOWER MCV AND RDW RESULTS, WHICH THE CUSTOMER CONSIDERS CORRECT SO CORRECTED REPORTS WERE AMENDED. THERE WAS NO DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. AC*T DIFF N/A

    Patients

    Seq Age Sex Outcome Treatment
    1