BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 SLIDEMAKER ANALYZER

    MDR report key: 1900785 · Received November 16, 2010

    Report

    Report Number
    1061932-2010-00217
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND WERE WITHIN ASSAYS LIMITS. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. ALL AUTOMATED SLIDES WERE CHECKED BY THE CUSTOMER. A FIELD SERVICE ENGINEER (FSE) PERFORMED TECHNICAL UPDATES NEEDED TO REDUCE SLIDEMAKER ELEVATED CARRYOVER LEVELS AND VERIFIED THE INSTRUMENT'S OPERATION. THE ROOT CAUSE FOR THE CARRYOVER IS MECHANICAL; THE CUSTOMER DID NOT FOLLOW INSTRUCTIONS TO MITIGATE THE PROBLEM DURING OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT ABNORMAL CELLULAR INCLUSIONS (AUER BODY) FROM A PREVIOUSLY RUN SPECIMEN WERE PRESENT ON A SINGLE PATIENT DIFFERENTIAL SLIDES PREPARED BY THE COULTER LH 750 SLIDEMAKER ANALYZER. ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SPECIMEN RESULTS WERE QUESTIONED AND A MANUAL SMEAR WAS MADE. THE REVIEW OF THE MANUAL SMEAR HAD NO ABNORMAL CELLULAR INCLUSIONS. A CORRECTED REPORT WAS ISSUED. 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 750 SLIDEMAKER ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1