BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2180922 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00681
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 2, 2010
    Report Date
    April 2, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EXAMINED THE SYSTEM AND NOTICED THAT THE QUALITY CONTROLS WERE OUT OF RANGE. INCOMPLETE MOTION OF THE BLOOD SAMPLING VALVE CENTER SECTION WAS NOTED. THE FSE THEN SERVICED THE VALVE AND RESEATED LOOSE TUBING ON THE BLOOD DETECTORS. SUBSEQUENTLY, THE FSE REPLACED THE BLOOD SAMPLING VALVE AND MULTIPLE TUBING THEN CALIBRATED THE SECONDARY MODE OF OPERATION. ALTHOUGH SEVERAL PARTS WERE REPLACED THE SPECIFIC ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. 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

    CUSTOMER REPORTED THAT ERRONEOUSLY HIGH PLATELET RESULTS WERE GENERATED BY A COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER FOR THREE PT SAMPLES. TWO OF THE PT SPECIMENS WERE RUN IN THE SECONDARY MODE AND THE THIRD SPECIMEN WAS RUN IN THE PRIMARY MODE. THE INSTRUMENT DID GENERATE APPROPRIATE FLAGS TO ALERT THE OPERATOR TO FURTHER REVIEW THE SAMPLE. THE RESULTS WERE REPORTED OUT OF THE LAB. THE PHYSICIANS QUESTIONED THE RESULTS AND A MANUAL SCAN WAS PERFORMED ON ALL THREE SPECIMENS. THE MANUAL PLATELET ESTIMATES WERE SIGNIFICANTLY LOWER FOR ALL THREE SPECIMENS. THE SAME THREE SPECIMENS WERE THEN RERUN IN PRIMARY MODE AND RECOVERED LOWER PLATELET RESULTS. THE THIRD SPECIMEN WAS RERUN ON THE BACKUP ACT 2 DIFF INSTRUMENT AND ALSO RECOVERED LOWER PLATELET RESULT. THESE LOWER PLATELET RECOVERY RESULTS WERE CONSIDERED CORRECT FOR ALL THREE PTS AND WERE REPORTED OUT. 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 HMX HEMATOLOGY ANALYZER WITH AUTOLOADER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK