BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 1853403 · Received October 5, 2010

    Report

    Report Number
    1061932-2010-00171
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). ACCORDING TO THE CUSTOMER, THE CHECKSUM DIGIT IS DISABLED. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE AND RERAN THE PATIENT BARCODE AND RECOVERED A 100% READ RATE. FSE ALSO REPLACED THE BARCODE READER AND CABLE RAN STARTUP AND CONTROLS TO VERIFY THE LH750 INSTRUMENT OPERATION. AS PER BCI LABELING: BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BAR-CODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 750 ANALYZER MIS-READ THE LAST DIGIT OF A SAMPLE ID FOR A PATIENT SPECIMEN (0 INSTEAD OF 7). THE OPERATOR NOTICED THE MIS-ID BECAUSE THE ACCESSION NUMBER HAD NO TEST ASSIGNED TO THE SPECIMEN AND THAT THE CHECKSUM IS DISABLED. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT IS ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1