BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 1904812 · Received November 22, 2010

    Report

    Report Number
    1061932-2010-00223
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 18, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SPECIMEN WAS COLLECTED IN A 5CC VACUTAINER TUBE AND SAMPLED WITHIN 30 MINUTES OF COLLECTION AND STORED AT ROOM TEMPERATURE. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN ASSAY RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND NO ISSUES AT THE TIME WITH THE ANALYZER. THE FSE RE-TUBED THE DIFFERENTIAL REAGENT PUMPS AND ADVISED THE CUSTOMER TO CONTACT THE BCI HOTLINE IF ISSUE RETURNS. THE FSE ALSO VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE BASED ON THE RAW DATA ANALYSIS IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    THE PATIENT SPECIMEN WAS COLLECTED IN A 5CC VACUTAINER TUBE AND SAMPLED WITHIN 30 MINUTES OF COLLECTION AND STORED AT ROOM TEMPERATURE. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN ASSAY RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE CONTROL RUN. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND FOUND NO ISSUES AT THE TIME WITH THE ANALYZER. THE FSE RE-TUBED THE DIFFERENTIAL REAGENT PUMPS AND ADVISED THE CUSTOMER TO CONTACT THE BCI HOTLINE IF ISSUE RETURNS. THE FSE ALSO VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE BASED ON THE RAW DATA ANALYSIS IS UNKNOWN. INSTEAD OF HIGH NE% AND LOW LY% IT SHOULD HAVE STATED LOW NE% AND HIGH LY%. THIS SECTION HAS BEEN CORRECTED IN THIS FOLLOW UP REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 500 INSTRUMENT PRODUCED AN ERRONEOUS DIFFERENTIAL (LOW NE% AND HIGH LY%) RESULT WITHOUT INSTRUMENT GENERATED FLAGS ON A SINGLE PATIENT SPECIMEN. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE DOCTOR QUESTIONED THE DIFFERENTIAL RESULTS. THE OPERATOR RERAN THE SPECIMEN AND VERIFIED THE RESULTS SLIDE REVIEW. THE RERUN INSTRUMENT RESULTS WERE SENT OUT AS CORRECTED RESULTS, WHICH THE CUSTOMER BELIEVES ARE CORRECT. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 500 INSTRUMENT PRODUCED AN ERRONEOUS DIFFERENTIAL (HIGH NE% AND LOW LY%) RESULT WITHOUT INSTRUMENT GENERATED FLAGS ON A SINGLE PATIENT SPECIMEN. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE DOCTOR QUESTIONED THE DIFFERENTIAL RESULTS. THE OPERATOR RERAN THE SPECIMEN AND VERIFIED THE RESULTS SLIDE REVIEW. THE RERUN INSTRUMENT RESULTS WERE SENT OUT AS CORRECTED RESULTS, WHICH THE CUSTOMER BELIEVES ARE CORRECT. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 INSTRUMENT AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1