BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 1050185 · Received May 22, 2008

    Report

    Report Number
    1415939-2008-00071
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LOM
    PMA / PMN Number
    P050051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS, NO CONCLUSION CAN BE DRAWN. THE BASIS FOR THIS REPORT IS THAT THERE IS A SIMILAR PRODUCT MARKETED IN THE UNITED STATES (US). THE US PRODUCT LIST NUMBER IS 1L82 AND IS MARKETED AS ARCHITECT AUSAB. THIS PRODUCT MEETS THE CRITERIA FOR A 5-DAY MDR AS DESCRIBED IN THE FDA'S NOTICE DATED APRIL 8, 2008 [TO MANUFACTURERS AND INITIAL DISTRIBUTORS OF MEDICAL DEVICES THAT MAY CONTAIN HEPARIN OR ARE HEPARIN-COATED], AND ABBOTT IS SUBMITTING THIS 5-DAY MDR. OUR INVESTIGATION INTO THIS EVENT IS ONGOING AND A SUPPLEMENTAL MDR WILL BE SUBMITTED AT THE CONCLUSION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    THE ACCOUNT STATED, THE ARCHITECT ANTI-HBS ASSAY IS GENERATING UNEXPECTED REACTIVE RESULTS. THE SAME ARCHITECT ANTI-HBS SPECIMENS TEST AXSYM AUSAB NEGATIVE. THE ARCHITECT ANTI-HBS CONTROLS ARE IN RANGE. THE ACCOUNT USED SERUM SAMPLES FOR TESTING. THE REACTIVE ARCHITECT ANTI-HBS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PT MANAGEMENT WAS REPORTED. HBSAG = 14.65 (NO UNITS OF MEASURE GIVEN, METHOD UNK). ARCHITECT ANTI-HBS = 24.02 MIU/ML REACTIVE. AXSYM AUSAB = 0.4 MIU/ML NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HBS CMIA FOR THE QUANTITATIVE DETERMINATION OF ANTIBODY TO HEPATITIS B SURFACE ANTIG LOM ABBOTT LABORATORIES NA 51297M100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ARCHITECT ANALYZER, LIST 3M74-01