BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3920377 · Received July 8, 2014

    Report

    Report Number
    1061932-2014-01550
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER CUSTOMER TECHNICAL SPECIALIST (CTS) ADVISED THE CUSTOMER TO CLEAN THE BSV (BLOOD SAMPLING VALVE) AND REPEAT THE NORMAL LEVEL CONTROL. THE INSTRUMENT WAS VERIFIED POST CLEANING BY OBTAINING QC (QUALITY CONTROL) RESULTS WITHIN THE ACCEPTABLE LIMITS. ON (B)(4) 2014, THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND VERIFIED THE INSTRUMENT AND FOUND NO FURTHER ISSUES. ALL CONTROLS AND REPRODUCIBILITY WERE SATISFACTORY. THE CLEANING OF THE BSV BY THE CUSTOMER RESOLVED THE ISSUE FOR DISCREPANT RBC (RED BLOOD CELL) AND HGB (HEMOGLOBIN) RESULTS ON PATIENT SAMPLES AND CONTROLS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS RED BLOOD CELL AND HEMOGLOBIN RESULTS WERE OBTAINED ON A SINGLE PATIENT SAMPLE RUN IN THE AUTOMATED MODE WHEN USING THE COULTER LH 500 HEMATOLOGY ANALYZER. THE ERRONEOUS TEST RESULTS DID NOT MATCH THE CLINICAL PICTURE AND PATIENT HISTORY. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO RESULTS THAT WERE OBTAINED IN THE MANUAL MODE USING THE SAME ANALYZER. TEST RESULTS OBTAINED IN THE MANUAL MODE WERE CONSIDERED CORRECT. THERE WERE NO ERRONEOUS TEST RESULTS REPORTED OUT OF THE LABORATORY ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397779 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1