BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC-T DIFF 2 ANALYZER

    MDR report key: 2180924 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00684
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 28, 2010
    Report Date
    May 20, 2010
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EXAMINED THE SYSTEM. THE FSE REPLACED THE HEMOGLOBIN (HGB) DIODE PRE-AMP BOARD AND VERIFIED THE INSTRUMENT'S OPERATION. THE ROOT CAUSE FOR THE ERRONEOUS HIGH HGB RESULTS WAS CAUSE BY THE DEFECTIVE HGB DIODE PRE-AMP BOARD THAT WAS SUBSEQUENTLY REPLACED DURING INSTRUMENT SERVICING. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT ERRONEOUS HIGH HEMOGLOBIN RESULTS WERE GENERATED BY THE COULTER AC-T DIFF 2 ANALYZER FOR MULTIPLE PT SAMPLES. THE INSTRUMENT DID GENERATE APPROPRIATE FLAGS TO ALERT THE OPERATOR TO FURTHER REVIEW THE SAMPLE. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. SPECIMENS WERE REDRAWN AND RUN ON A DIFFERENT INSTRUMENT. CORRECTED REPORTS WERE SENT OUT OF THE LAB. THERE WAS NO DEATH, INJURY OR CHANGE TO THE PTS' CARE OR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC-T DIFF 2 ANALYZER GKZ BECKMAN COULTER INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK