BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4101907 · Received September 19, 2014

    Report

    Report Number
    1061932-2014-02391
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 20, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE FOUND A PIN-SIZED HOLE IN THE PAK LYSE LINE TO PORT 6 OF THE BLOOD SAMPLING VALVE. THE FSE CUT AND REATTACHED THE TUBING TO RESOLVE THE ISSUE. IN ADDITION, THE FSE REPLACED THE PAK LYSE PUMP AND ADJUSTED THE VOLUME OF THE PUMP AS PART OF TROUBLESHOOTING. ASSOCIATED MDR: 1061932-2014-02390. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COULTER LH 500 HEMATOLOGY ANALYZER GENERATED ERRONEOUS NEUTROPHIL AND MONOCYTE RESULTS WITH SUSPECT MESSAGING AS WELL AS INCOMPLETE DIFFERENTIAL RESULTS OVER TWO DAYS FOR FOUR PATIENT SAMPLES. IN ADDITION, THE CUSTOMER NOTED AN INCREASE IN FLAGGING ON NORMAL PATIENT DIFFERENTIAL RESULTS. SOME OF THE AFFECTED RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER AMENDED THE RESULTS AND THERE WAS NO IMPACT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QUALITY CONTROL RESULTS BEFORE AND AFTER THE INCIDENT WERE WITHIN SPECIFICATIONS. THIS MDR REPORTS THE RESULTS GENERATED ON (B)(6) 2014. ON (B)(6) 2014, THE INSTRUMENT GENERATED INCOMPLETE RESULTS FOR DIFFERENTIAL PARAMETERS FOR TWO PATIENT SAMPLES AS WELL AS ERRONEOUS NEUTROPHIL AND MONOCYTE RESULTS FOR ONE PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582658 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR