BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 1873150 · Received October 18, 2010

    Report

    Report Number
    1061932-2010-00181
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    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

    A SAMPLE BARCODE LABEL WAS OBTAINED FROM THE CUSTOMER AND CHECKED WITH A BARCODE VERIFIER. THE RESULTS ARE LISTED BELOW: THE SAMPLE BARCODE LABEL FAILED LH700 SERIES LABEL SPECIFICATIONS FOR REFLECTIVITY OF MEDIA. CONFIRMED LABEL SYMBOLOGY IS CODABAR WITH NO CHECK CHARACTER. THE CHECKSUM WAS DISABLED. PER LABELING, BCI STRONGLY RECOMMENDS THE USE OF BARCODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A SAMPLE BARCODE LABEL WAS EXAMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A SAMPLE ID THAT WAS MISREAD BY COULTER LH750 HEMATOLOGY ANALYZER. SAMPLE ID (B)(6) WAS MISREAD AS (B)(6). THE MISREAD WAS IDENTIFIED AS A RESULT OF A NO MATCH MESSAGE. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLE RESULTS WERE EDITED WITH THE CORRECT SAMPLE ID AND THE CORRECTED REPORT WAS RELEASED TO THE PHYSICIAN. THERE WAS NO DEATH, 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 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1