BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2257906 · Received September 21, 2011

    Report

    Report Number
    1061932-2011-01513
    Event Type
    Malfunction
    Date Received
    September 21, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS AN INTRAVENOUS WHOLE BLOOD, COLLECTED IN A PURPLE TOP TUBE. QC WAS RUN BEFORE THE EVENT. THE SYSTEM WAS PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS FOR THIS EVENT. RAW DATA FOR BOTH INSTRUMENTS WAS REQUESTED; HOWEVER, ONLY RAW DATA FILES FOR LH750 WERE PROVIDED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011: THE FSE NOTED THAT RET QC HAS BEEN GENERATING R FLAGS SINCE MAY. "(R - INSTRUMENT-GENERATED FLAG; REVIEW THE RESULT ACCORDING TO YOUR LABORATORY'S PROTOCOL. WHEN EDITING PARAMETER RESULTS, THIS FLAG REQUIRES SPECIAL HANDLING. ANY PARAMETER DERIVED FROM AN R-FLAGGED PARAMETER CANNOT BE RECALCULATED UNTIL THE PARAMETERS WITH THE R FLAGS HAVE BEEN EDITED)." THE FSE FOUND MISSING LIGHT SHIELD ON FLOW CELL AND REPLACED. THE FSE ALSO REPLACED SAMPLE TUBING FROM MIX CHAMBERS TO FLOW CELL AND CLEANED FLOW CELL SURFACE AND LASER LENS. THE FSE ADJUSTED RET SAMPLE PRESSURE AND TESTED TO PROPER OPERATION. RET R FLAGS NO LONGER OCCUR. CUSTOMER TO MONITOR THE INSTRUMENT. ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BEC) AND REPORTED THAT THE RETICULOCYTES (RET) RESULTS GENERATED BY COULTER LH 750 HEMATOLOGY ANALYZER, WITH NO INSTRUMENT GENERATED FLAGS, WERE HIGHER THAN THE INITIAL RET RESULTS OBTAINED ON A DIFFERENT SYSTEM. THE DISCREPANCY WAS NOTED AFTER THE SPECIMEN WAS RERUN ON THE LH750 INSTRUMENT FOR COMPARISON PURPOSES. THE RESULTS FROM THE LH750 INSTRUMENT WERE NOT REPORTED OUT OF THE LAB. THE RET RESULT FROM THE DIFFERENT INSTRUMENT WAS REPORTED AS CORRECT BECAUSE IT WAS CONSISTENT WITH THE LOW RESULTS OBTAINED BY MANUAL SLIDE REVIEW. MANUAL RESULTS NOT SUPPLIED. THERE WAS NO DEATH, INJURY OR AN EFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR