BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF ANALYZER

    MDR report key: 3072808 · Received April 23, 2013

    Report

    Report Number
    1061932-2013-00681
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K992511
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT. THE FSE PERFORMED INSTRUMENT VERIFICATION PROCEDURES, VERIFIED LAMP VOLTAGE AND REPLACED LAMP DUE TO ERRATIC VOLTAGE PARAMETERS. THE FSE MANUALLY PURGED DIFFERENTIAL LINE AFTER REPLACING THE DIFFERENTIAL SYRINGE. THE FSE TESTED PARTS, AND UPON FURTHER INVESTIGATION REPLACED THE MAIN PRINTED CIRCUIT BOARD (PCB) CARD. THE FSE PERFORMED DIFFERENTIAL ADJUSTMENT, AND THEN RUN CONTROLS AND SAMPLES. FAILURE MODE WAS THE PCB MAIN BOARD.

    Description of Event or Problem · 1

    BECKMAN COULTER DISTRIBUTOR REPORTED THAT ERRATIC DIFFERENTIAL RESULTS WERE GENERATED BY THE COULTER AC T 5DIFF ANALYZER. INSTRUMENT PRINTOUTS AND EVENT DETAILS HAVE BEEN REQUESTED, BUT HAVE NOT BEEN PROVIDED. SAMPLE INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED. IT IS UNKNOWN IF THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS UNKNOWN IF THERE WAS ANY DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174879 COULTER® AC T 5DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT 5DIFF NA

    Patients

    Seq Age Sex Outcome Treatment
    1