BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT COMMANDER FPC

    MDR report key: 870156 · Received June 25, 2007

    Report

    Report Number
    1628664-2007-00314
    Event Type
    Other
    Date Received
    June 25, 2007
    Report Date
    June 4, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JQW
    PMA / PMN Number
    K894069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF SERVICE TEXT FROM COMPLAINT. THE FIELD SERVICE ENGINEER PERFORMED ROUTINE CLEANING, CALIBRATING, AND ADJUSTMENT PROCEDURES FOR THE BARCODE READER. A REVIEW WAS PERFORMED OF THE COMPLAINT TEXT AND SERVICE HISTORY FOR THE COMMANDER FPC. FIELD SERVICE PERFORMED ROUTINE MAINTENANCE PROCEDURES FOR CLEANING, CALIBRATING AND ADJUSTING THE BARCODE READER. THE ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER OPERATIONS MANUAL, LIST NUMBER 6A97-27, TROUBLESHOOTING AND DIAGNOSTICS, TROUBLESHOOTING, A BAR CODE HAS BEEN MISREAD SECTION: CONTAINS INFORMATION ABOUT TROUBLESHOOTING A MISREAD BAR CODE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THERE WERE A TOTAL OF 8 BARCODE MISREADS WITH TWO COMMANDER FPC BETWEEN 2006 AND 2007 WHEN PIPETTING HIV-1/2 EIA, HTLV-I/II EIA AND HCV 2.0 EIA ASSAYS. THIS REPORT IS FOR BARCODE MISREAD #7. NO SPECIFIC BARCODE INFORMATION IS AVAILABLE. THE SAME BARCODE ID WAS ALSO PROCESSED ON THE PRISM ANALYZER WITH CORRECT BARCODE IDENTIFICATION. NO SPECIFIC PATIENT INFORMATION IS AVAILABLE. THE ACCOUNT RECOGNIZED THE INCORRECT BARCODE ID PRIOR TO RESULTS BEING REPORTED. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. SERVICE WAS REQUESTED FOR THE COMMANDER FPC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT COMMANDER FPC AUTOMATED SYSTEM FOR THE PROCESSING OF EIAS JQW ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN FPC LIST 3A46-47| HIV-1/2 EIA LIST 3A77| HCV 2.0 EIA LIST 4A14| HTLV-I/II LIST 7A92