BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT COMMANDER FPC

    MDR report key: 870170 · Received June 25, 2007

    Report

    Report Number
    1628664-2007-00306
    Event Type
    Other
    Date Received
    June 25, 2007
    Date of Event
    March 14, 2007
    Report Date
    June 1, 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

    RESULTS: EVALUATION OF SERVICE TEXT FROM COMPLAINT. THE FIELD SERVICE ENGINEER PERFORMED A PROACTIVE REPLACEMENT OF THE FUNCTIONAL BARCODE READER AS A PRECAUTION. A REVIEW WAS PERFORMED OF THE COMPLAINT TEXT AND SERVICE HISTORY FOR THE COMMANDER FPC. THE CUSTOMER IS NOT ABLE TO DETERMINE IF THE MISREADS WERE CAUSED BY THE READER ITSELF OR THE BARCODE LABEL ON THE TUBES AS THE TUBES ARE NO LONGER AVAILABLE. FIELD SERVICE REPLACED THE BARCODE READER AS A PRECAUTION, AS THE EXISTING BARCODE READER WAS OPERATING AS DESIGNED. THE ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER OPERATIONS MANUAL, SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, TROUBLESHOOTING, A BARCODE HAS BEEN MISREAD SECTION: CONTAINS INFORMATION ABOUT TROUBLESHOOTING A MISREAD BARCODE. 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 5 BARCODE MISREADS. THIS REPORT IS FOR BARCODE MISREAD #4 IN 2007. 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 YR HTLV-I/II| HCV 2.0 EIA| HIV-1/2 EIA