BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT HTLV-I/HTLV-II EIA

    MDR report key: 992393 · Received February 7, 2008

    Report

    Report Number
    1415939-2008-00027
    Event Type
    Other
    Date Received
    February 7, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 8, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LRM
    PMA / PMN Number
    103614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED WHILE THEY WERE PERFORMING AN EQUIPMENT VALIDATION ON THE QUANTUM II, ABBOTT NEGATIVE CONTROLS THAT WERE BEING RUN AS PATIENT SAMPLES GENERATED REACTIVE RESULTS JUST ABOVE THE CUTOFF ON THE HTLV I/II EIA. IN ADDITION, EIGHT PATIENT SAMPLES OBTAINED FROM A REFERENCE LAB THAT PREVIOUSLY TESTED NEGATIVE BY BIOMERIEUX IFA, GENERATED REACTIVE RESULTS. THIS REPORT IS TO DOCUMENT PATIENT SAMPLE ID THAT GENERATED A REACTIVE ABSORBANCE RESULT OF 0.502 BASED ON A CUTOFF OF 0.439. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT HTLV-I/HTLV-II EIA EIA FOR DETECTION OF HTLV-I/HTLV-II ANTIBODIES LRM ABBOTT LABORATORIES NA 53004M200

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK QUANTUM II LIST # 3303-86