BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3081396 · Received April 26, 2013

    Report

    Report Number
    1061932-2013-00731
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 2, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED THAT THE CAUSE OF THIS ISSUE WAS THE LH SERIES PAK SINCE REPLACING THE PAK CLEARED THE PROBLEM. HOWEVER, THE CUSTOMER CALLED IN TO REPORT THAT INCOMPLETE DIFFERENTIAL (NON-NUMERIC) RESULTS WERE GENERATED WHEN THE PROBLEM RE-OCCURRED AGAIN THE NEXT DAY. THE FSE WENT BACK TO THE CUSTOMER SITE ON (B)(4) 2013 AND CONFIRMED THERE WERE NO DIFFERENTIAL RESULTS UPON ARRIVAL AND TRIED A NEW LH PAK WITHOUT IMPROVEMENT. UPON FURTHER INVESTIGATION, THE FSE DISCOVERED THAT THE DIFFERENTIAL LYSE PUMP WAS PUMPING ERRATICALLY AND THAT THE RETURN SPRING WAS BROKEN AND REPLACED THE PUMP. THE FSE FOUND THE PUMP WAS STILL PUMPED ERRATICALLY AND DETERMINED THERE WAS AN OCCLUSION IN THE LEFT MOST SHEAR VALVE. THE FSE ORDERED A NEW VALVE AND ON (B)(4) 2013 REPLACED THE SHEAR VALVE 85/126 TO REPAIR THE INSTRUMENT. FAILURE MODE WAS THE DIFFERENTIAL SHEAR VALVE 85/126. THE SAMPLES GAVE INCOMPLETE COMPUTATION (NON-NUMERIC RESULTS) WHICH ALERTED THE CUSTOMER TO A PROBLEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT THAT THE COULTER LH 750 HEMATOLOGY ANALYZER GAVE INCOMPLETE DIFFERENTIAL (NON-NUMERIC) RESULTS. THERE WERE NO ERRONEOUS RESULTS GENERATED. CORRECT RESULTS WERE OBTAINED BY RERUNNING THE PATIENT SAMPLES ON ANOTHER INSTRUMENT. CONTROLS WERE RUN BEFORE THE INCIDENT AND RECOVERED WITHIN THE ASSAY RANGE. PREVIOUSLY-RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. PRINTOUTS ARE NO LONGER AVAILABLE. THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180862 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1