BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT DIFF ANALYZERS

    MDR report key: 2183621 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00817
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    April 15, 2008
    Report Date
    April 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED VIA FINGERSTICK. QUALITY CONTROL FOR THE INSTRUMENT WAS WITHIN SPECS. (B)(4) 2008, THE FIELD SERVICE ENGINEER VERIFIED INSTRUMENT PERFORMANCE TO SPECS. H6: REVIEW OF THE DATA PROVIDED IS INDICATIVE OF INADEQUATE SAMPLE HANDLING/MIXING. REVIEW OF PRODUCT LABELING IDENTIFIED THE FOLLOWING: "WHEN WBC AND PLT ARE TOO HIGH OR LOW, HGB AND RBC ARE OPPOSITE, TOO LOW OR HIGH, THE PROBABLE CAUSE IS THE SAMPLE WAS NOT ADEQUATELY MIXED BEFORE ASPIRATION. THE SUGGESTED ACTION IS TO REMIX THE SAMPLE AND CYCLE IT AGAIN." ROOT CAUSE IS UNK, BUT MAY BE ATTRIBUTED TO PRE-ANALYTICAL SAMPLE HANDLING/MIXING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS COMPLETE BLOOD COUNT (CBC) RESULTS FOR ONE PT SAMPLE WHILE USING THE COULTER ACT DIFF ANALYZER. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LAB. SAMPLE WAS RERUN WITH CORRECT TEST RESULTS OBTAINED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT DIFF ANALYZERS GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK