BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT COMMANDER FPC

    MDR report key: 870163 · Received June 25, 2007

    Report

    Report Number
    1628664-2007-00308
    Event Type
    Other
    Date Received
    June 25, 2007
    Date of Event
    April 30, 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 TEST 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, SECTION 10, 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 THAT UPON REVIEW OF COMMANDER FPC RECORDS OBSERVED BARCODE MISREADS WITH COMMANDER FPC WHEN PIPETTING HIV 1/2 EIA, HTLV-I/II EIA AND HCV 2.0 EIA ASSAYS. THERE WERE A TOTAL OF 8 BARCODE MISREADS BETWEEN TWO COMMANDER FPC SERIAL OF 8 BARCODE MISREADS BETWEEN TWO COMMANDER FPC. THIS REPORT IS FOR BARCODE MISREAD #1, WHERE BARCODE READS IN 2007. THE SAME BARCODE ID WAS ALSO PROCESSED ON THE PRISM ANALYZER WITH CORRECT BARCODE IDENTIFICATION. NO SPECIFIC PATIENT INFO 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 PT 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 YR FPC LIST 3A46-47| HIV-1/2 EIA LIST 3A77| HCV 2.0 EIA LIST 4A14| HTLV-I/II LIST 7A92