BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HAVAB IGM REAGENT

    MDR report key: 1834013 · Received September 14, 2010

    Report

    Report Number
    2623532-2010-00068
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    ABBOTT
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED UPON CURRENT INFORMATION, IT HAS BEEN DETERMINED THAT ELEVATED (B)(6) PATIENT RESULTS, OR ELEVATED OUT OF RANGE HIGH (B)(6) QUALITY CONTROL RESULTS FOR ARCHITECT HAVAB-IGM MAY OCCUR WHEN THE ASSAY IS RUN DIRECTLY FOLLOWING THE ARCHITECT ANTI-HBS ASSAY. ARCHITECT HAVAB-IGM, LIST NUMBER 6L21-25 IS CURRENTLY THE FOCUS OF A PRODUCT CORRECTION, REPORTED UNDER 2623532-1/4/10-001-C. THIS REPORT IS BEING FILED FOR THE INTERNATIONAL PRODUCT, ARCHITECT HAVAB-IGM, LIST NUMBER 6C30. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE ISSUE WAS DETERMINED TO BE REDUCED POTENCY OF THE ACTIVE ANTIGEN (B)(4). ELEVATED OR OUT OF RANGE HIGH NEGATIVE CONTROL RESULTS AND/OR ELEVATED GRAYZONE / REACTIVE RESULTS MAY BE OBSERVED FOR THE ARCHITECT HAVAB-IGM ASSAY, LIST NUMBER 6C30, WHEN IT IS RUN ON THE SAME MODULE WITH THE ARCHITECT ANTI-HBS, LIST NUMBER 7C18. THIS ISSUE HAS THE POSSIBILITY TO OCCUR WHEN THE ARCHITECT AUSAB / ANTI-HBS ASSAY PRECEDES THE ARCHITECT HAVAB-M / HAVAB-IGM ASSAY DURING TESTING. ADDITIONALLY, THERE IS THE POTENTIAL TO GENERATE ELEVATED RESULTS EVEN WHEN ARCHITECT AUSAB/ANTI-HBS IS NOT RUN ON THE SAME MODULE. THE INVESTIGATION IDENTIFIED THE CAUSE AS A REDUCED POTENCY OF THE HAV ANTIGEN (B)(4). THIS LEADS TO LOWER ICAL RLU VALUES AND ELEVATED SIGNAL FROM NEGATIVE SAMPLES, WHICH IN TURN HAS THE POTENTIAL TO CAUSE INCREASED FALSE GRAYZONE/POSITIVE 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 (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE QUALITY CONTROL FOR HAVAB-IGM WAS SHIFTING UPWARD AND (B)(6) RESULTS WERE OCCURRING. ANTI-HBS IS PERFORMED ON THE SAME ANALYZER AND THE CUSTOMER IS CURRENTLY NOT FOLLOWING THE INSTRUCTIONS CONTAINED IN FA24FEB2010. ARCHITECT HAVAB-IGM IS CURRENTLY THE FOCUS OF A PRODUCT CORRECTION. CURRENT INFORMATION INDICATES THAT (B)(6) PATIENT RESULTS, OR ELEVATED OUT OF RANGE HIGH (B)(6) QUALITY CONTROL RESULTS FOR ARCHITECT HAVAB-IGM MAY OCCUR WHEN THE ASSAY IS RUN DIRECTLY FOLLOWING THE ARCHITECT ANTI-HBS ASSAY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000, LN 8C89-92, (B)(4)| ARCH I2000, LN 8C89-92, (B)(4)