BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2171251 · Received July 1, 2011

    Report

    Report Number
    1061932-2011-00741
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Report Date
    February 21, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHECKSUM FEATURE OF THE (B)(4) IS DISABLED. SAMPLE BARCODE LABELS WERE REQUESTED, BUT NOT PROVIDED. BARCODE LABEL SYMBOLOGY IS UNK. FIELD SERVICE WAS NOT DISPATCHED. ROOT CAUSE WAS DETERMINED TO BE THE LACK OF CHECKSUM DIGITS IN BARCODES AND FAILURE TO USE THE CHECKSUM FEATURE OF THE (B)(4). PRODUCT LABELING STATES "BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BAR-CODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. IMPORTANT: USE OF BAR-CODES IS AN EXTREMELY ACCURATE AND EFFECTIVE METHOD OF POSITIVE PT IDENTIFICATION. CERTAIN FEATURES, SUCH AS CHECKSUM DIGITS, MAXIMIZE ACCURACY IN READING CODABAR, CODE 39 AND INTERLEAVED 2-OF-5 LABELS.(B)(4). USE CHECKSUMS TO PROVIDE PROTECTION AGAINST OCCASIONAL MISREAD ERRORS CAUSED BY PROBLEMS SUCH AS DAMAGED OR MISAPPLIED LABELS. IF YOU MUST USE BAR-CODES WITHOUT CHECKSUMS, BECKMAN COULTER RECOMMENDS THAT YOU VERIFY EACH BAR-CODE READING TO ASSURE CORRECT PT IDENTIFICATION." THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SAMPLE MISIDENTIFICATION WHILE USING THE COULTER (B)(4) HEMATOLOGY ANALYZER. DETAILED INFO CONCERNING THE NUMBER OF SAMPLES, DATES OF OCCURRENCE, AND INSTRUMENT PRINTOUTS WERE NOT PROVIDED. CUSTOMER IS VERIFYING THE SAMPLE IDENTIFICATION ON THE SAMPLE TUBES TO ENSURE IDENTIFICATION IS CORRECT. NO ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK