BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC-T DIFF 2 ANALYZER

    MDR report key: 2171207 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00790
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT WAS WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). QC WAS RUN BEFORE, BUT NOT AFTER THE INCIDENT AND WAS WITHIN RANGE. THE FIELD SERVICE ENGINEER DID NOT EVALUATE THE ANALYZER. THE CUSTOMER REPORTED TO THE FSE THAT THE MIXER ON SITE WAS 'OLD', NEEDED TO BE REPLACED, AND WAS RECOGNIZED TO HAVE PROBABLY CONTRIBUTED TO THE ERRONEOUS RESULTS. CUSTOMER IS IN THE PROCESS OF OBTAINING A NEW BLOOD MIXER. PRINTOUTS PROVIDED CONFIRMED THE REPORTED PROBLEM. REVIEW OF THE DATA PROVIDED IS INDICATIVE OF INADEQUATE SAMPLE MIXING. CONTACT WITH LABORATORY MANAGER ON 04/17/2008 CONFIRMED NO FURTHER INCIDENTS HAVE OCCURRED SINCE THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS TEST RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES WHILE USING THE COULTER AC-T DIFF 2 ANALYZER. THE ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO EFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Additional Manufacturer Narrative · 2

    INSTRUMENT WAS WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). QC WAS RUN BEFORE, BUT NOT AFTER THE INCIDENT AND WAS WITHIN RANGE. THE FIELD SERVICE ENGINEER DID NOT EVALUATED THE ANALYZER. THE CUSTOMER REPORTED TO THE FSE THAT THE MIXER ON SITE WAS 'OLD', NEEDED TO BE REPLACED, AND WAS RECOGNIZED TO HAVE PROBABLY CONTRIBUTED TO THE ERRONEOUS RESULTS. CUSTOMER IS IN THE PROCESS OF OBTAINING A NEW BLOOD MIXER. PRINTOUTS PROVIDED CONFIRMED THE REPORTED PROBLEM. REVIEW OF THE DATA PROVIDED IS INDICATIVE OF INADEQUATE SAMPLE MIXING. CONTACT WITH LABORATORY MANAGER ON 04/17/2008 CONFIRMED NO FURTHER INCIDENTS HAVE OCCURRED SINCE THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 2

    CUSTOMER REPORTED ERRONEOUS TEST RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES WHILE USING THE COULTER AC-T DIFF 2 ANALYZER. THE ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    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
    2 UNK