BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® PREPPLUS 2

    MDR report key: 3121487 · Received May 21, 2013

    Report

    Report Number
    1061932-2013-00915
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FLOW COUNT IS A BEAD SUSPENSION USED IN SOME FLOW CYTOMETRY APPLICATIONS TO GENERATE DATA USED TO CALCULATING ABSOLUTE COUNTS FOR LYMPHOCYTE SUB-SETS. FLOW COUNT MUST BE MIXED WELL ACCORDING TO SPECIFIC INSTRUCTIONS TO SUSPEND THE BEADS IN SOLUTION. FAILURE OF THE FLOW COUNT PLATE COULD RESULT IN ERRONEOUS ABSOLUTE COUNT RESULTS. A NEW MIXER MOTOR HAS BEEN ORDERED AND WILL BE INSTALLED WHEN IT ARRIVES. CAUSE OF THE PROBLEM WAS ATTRIBUTED TO FAILURE OF THE MIXER MOTOR. (B)(4).

    Description of Event or Problem · 1

    (B)(4) DISTRIBUTOR REPORTED TO BECKMAN COULTER (BEC) THAT THE FLOW COUNT PLATED WAS NOT MIXING ON THE COULTER PREPPLUS2 DUE TO FAILURE OF THE MIXER MOTOR. THE FAILURE HAS BEEN DETECTED BY THE BIOCHEMMACK`S FIELD SERVICE ENGINEER (FSE). THE PREPPLUS2 IS USED TO PREPARE SAMPLES FOR ANALYSIS. THE CUSTOMER DOES NOT CURRENTLY USE FLOW COUNT, THEREFORE THERE WERE NO INCORRECTLY PREPARED SAMPLES. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY. THERE WAS NO DEATH, INJURY, OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224439 COULTER® PREPPLUS 2 STATION, PIPETTING AND DILUTING, FOR CLINICAL USE JQW BECKMAN COULTER PREP PLUS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1