BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER FC500 FLOW CYTOMETER

    MDR report key: 2339999 · Received November 15, 2011

    Report

    Report Number
    1061932-2011-02121
    Event Type
    Malfunction
    Date Received
    November 15, 2011
    Date of Event
    July 15, 2009
    Report Date
    July 15, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K071681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. IT WAS DETERMINED THAT THE SITE'S SAMPLE IDENTIFICATION (ID1) IS AN 8-DIGIT NUMBER WHICH REPRESENTS PART OF THE PATIENT'S MEDICAL RECORD NUMBER. THE LIS HAS A 10-DIGIT NUMBER WITH THE FIRST 2 CHARACTERS STRIPPED BY DATA INNOVATIONS (DI) INSTRUMENT MANAGER FOR USE AS SAMPLE ID1 IN CXP SOFTWARE FOR THE FC500 FLOW CYTOMETER. THE DATA INNOVATIONS INSTRUMENT MANAGER IS NOT A BECKMAN COULTER INC PRODUCT. IN THIS CASE LIS MEDICAL RECORD NUMBER (B)(6) BECOMES (B)(6) AT DI WHICH IS IMPLEMENTED AS SAMPLE ID1 AT CXP/CXP REPORT GENERATOR. THE HOSPITAL CHANGES THE FIRST 2 CHARACTERS OF THE MEDICAL RECORD NUMBERS PERIODICALLY, E.G. (B)(6). THE REMAINING 8 DIGITS OF THE MEDICAL RECORD NUMBER MAY BE RECYCLED BY THE LABORATORY. THE ROOT CAUSE ATTRIBUTED THIS EVENT TO THE CUSTOMER RECYCLING THE 8 DIGITS OF THE MEDICAL RECORD NUMBER (SAMPLE ID1). IT WAS RECOMMENDED THAT THE CUSTOMER DEVELOP A STRATEGY FOR HANDLING THE REUSE OF SAMPLE ID1 WHILE MAINTAINING UNIQUE SAMPLE IDENTIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RESULTS TRANSFERRED ELECTRONICALLY FROM THE FC500 FLOW CYTOMETER THROUGH DATA INNOVATIONS MIDDLEWARE TO THE LIS (LABORATORY INFORMATION SYSTEM) HAD THE INCORRECT PATIENT NAME. THE PANEL REPORT PRINTOUT FROM THE FC500 HAD THE WRONG PATIENT NAME ON THE REPORT. THERE WERE NO ERRONEOUS OR MISIDENTIFIED PATIENT RESULTS REPORTED OUTSIDE THE LABORATORY AS THE ERROR WAS CAUGHT AND CORRECTED BY THE OPERATOR DURING A ROUTINE REVIEW OF THE DATA AFTER THE RUN. THERE WERE NO REPORTED CHANGES TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER FC500 FLOW CYTOMETER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK