BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2223180 · Received August 12, 2011

    Report

    Report Number
    1061932-2011-01128
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    November 10, 2009
    Report Date
    November 18, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THE CUSTOMER BARCODE SYMBOLOGY WAS CODABAR WITH 11 CHARACTERS. BARCODE LABELS WERE REQUESTED BUT WERE NOT PROVIDED BY THE CUSTOMER. THE BARCODE CHECKSUM SOFTWARE ALGORITHM FOR THE LH750 ANALYZER WAS DISABLED ON THE CUSTOMER'S INSTRUMENT. PER BECKMAN COULTER LABELING, THE USE OF BAR CODE CHECKSUMS IS STRONGLY RECOMMENDED IN ORDER TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. A FIELD SERVICE ENGINEER WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LH750 HEMATOLOGY ANALYZER MIS-READ THE FIRST DIGIT OF A BAR CODE LABEL ON ONE PT SAMPLE. THE SAMPLE BARCODE (B)(4) WAS MISREAD AS (B)(4). THE OPERATOR NOTICED THE INCORRECT SAMPLE ID (IDENTIFICATION) AND CORRECTED THE ID NUMBER BEFORE SENDING PT RESULTS TO THE LABORATORY INFO SYSTEM FOR RELEASE. THERE WERE NO ERRONEOUS OR MIS-IDENTIFIED RESULTS REPORTED OUTSIDE OF THE LABORATORY. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK