BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC T DIFF ANALYZER

    MDR report key: 1052483 · Received May 22, 2008

    Report

    Report Number
    1061932-2008-00031
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN ONCE PER DAY AND WAS RUN BEFORE THE EVENT. QC WAS NOT PERFORMED AFTER THE EVENT. A FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LAB: THE FSE REPLACED 2 BATH DRAIN SOLENOID VALVES, VERIFIED AND VALIDATED THE INSTRUMENT. ALTHOUGH THE FSE ADDRESSED HARDWARE ISSUE, A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW HEMOGLOBIN (HGB) RESULTS GENERATED BY THE COULTER AC T DIFF ANALYZER FOR THREE DIFFERENT PT SAMPLES. THE SAMPLES WERE ALSO TESTED ON A DIFFERENT INSTRUMENT IN THE CUSTOMER'S LAB. HGB RESULTS OBTAINED FROM THE AC T DIFF ANALYZER WERE LOWER WHEN COMPARED TO HGB RESULTS GENERATED BY THE DIFFERENT INSTRUMENT. THE RESULTS OBTAINED FROM THE DIFFERENT INSTRUMENT WERE CONSIDERED CORRECT. THE HGB RESULTS FROM BOTH INSTRUMENTS WERE PRINTED WITH "L" FLAGS. (L=RESULT IS LOWER THAN THE LOW PT SAMPLE LIMIT). THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. BASED ON INFO PROVIDED, THERE WAS NO IMPACT TO PT 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA