BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 1962041 · Received January 17, 2011

    Report

    Report Number
    2623532-2011-00004
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    LOL
    PMA / PMN Number
    N/A
    Removal / Correction Number
    2623532-1/4/10-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE CAUSE OF THE ISSUE WAS DETERMINED TO BE REDUCED POTENCY OF THE ACTIVE ANTIGEN WHICH IS COATED ON THE MICROPARTICLE COMPONENT OF THE ASSAY. ELEVATED (B)(6) RESULTS MAY BE OBSERVED FOR THE ARCHITECT HAVAB-M (US) ASSAY (LN 6L21) WHEN IT IS RUN ON THE SAME MODULE WITH THE ARCHITECT AUSAB (LN 1L82). THE INVESTIGATION IDENTIFIED THE CAUSE AS A REDUCED POTENCY OF THE HAV ANTIGEN WHICH IS COATED ON THE MICROPARTICLE COMPONENT OF THE ASSAY. THIS LEADS TO LOWER ICAL RLU VALUES AND ELEVATED SIGNAL FROM NEGATIVE SAMPLES, WHICH IN TURN HAS THE POTENTIAL TO CAUSE INCREASED FALSE (B)(6) RESULTS, INCREASED SUSCEPTIBILITY TO REAGENT CROSS CONTAMINATION (E.G. ARCHITECT ANTI-HBS/AUSAB), AND / OR INCREASED IMPACT OF NATURALLY OCCURRING TEST SYSTEM VARIABILITY ON FINAL TEST RESULTS. CONTROL MEASURES INCLUDE RAW MATERIAL QUALIFICATION AND IMPLEMENTATION OF MANUFACTURING CONTROLS FOR CALIBRATOR RLU VALUES. CURRENT MODES OF CONTROL WERE COMMUNICATED TO ARCHITECT HAVAB-IGM CUSTOMERS THROUGH PRODUCT CORRECTION LETTER FA24FEB2010 AND WILL REMAIN IN EFFECT UNTIL CORRECTIVE ACTIONS TO ADDRESS THE REDUCED POTENCY OF THE HAV ANTIGEN HAVE BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT WHILE PERFORMING A COMPARISON STUDY WITH THE ARCHITECT I1000SR AND AXSYM ANALYZERS, THE NEGATIVE AND POSITIVE HAVAB IGM CONTROLS WERE OUT OF RANGE. ADDITIONALLY, THE CUSTOMER STATED (B)(6) RESULTS WERE GENERATED ON THE ARCHITECT FOR SOME OF THE COMPARISON SAMPLES. AN INVESTIGATION HAS REVEALED THAT THERE IS A POTENTIAL TO GENERATE FALSE (B)(6) ARCHITECT HAVAB-M RESULTS WHEN THE ARCHITECT AUSAB ASSAY PRECEDES THE ARCHITECT HAVAB-M ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HAVAB IGM REAGENT FOR THE DETECTION OF IGM ANTIBODIES TO HEPATITIS A VIRUS LOL ABBOTT DIAGNOSTICS INT'L, LTD 89235Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I1000SR, 1L86*01, (B)(4)