BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 1050186 · Received May 22, 2008

    Report

    Report Number
    1415939-2008-00072
    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. ENTRY IS THE PMA NUMBER FOR THE US PRODUCT. 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 PATIENT MANAGEMENT WAS REPORTED. SPECIMEN (PATIENT 5 OF 8). HBSAG = 353.96 (NO UNITS OF MEASURE GIVEN, METHOD UNKNOWN). ARCHITECT ANTI-HBS = 26.03 MIU/ML REACTIVE. AXSYM AUSAB = 4.6 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