BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 1412069 · Received July 11, 2009

    Report

    Report Number
    1628664-2009-00265
    Event Type
    Malfunction
    Date Received
    July 11, 2009
    Date of Event
    June 18, 2009
    Report Date
    June 18, 2009
    Manufacturer
    ABBOTT GMBH & CO. KG
    Product Code
    MZF
    PMA / PMN Number
    K983212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSATIVE AGENT HAS BEEN CHANGED FROM THE ARCHITECT ANALYZER (B)(4) TO (B)(4) WHICH IS AN INTERNATIONAL PRODUCT. EVALUATION (B)(4), OTHER: RETAINED KIT TESTING OF THE REAGENT LOTS MET ALL SPECIFICATIONS. THE CUSTOMER PREVIOUSLY STATED THAT IT WAS UNKNOWN IF THE ISSUE WAS A FALSE POSITIVE OR FALSE NEGATIVE, BUT NOW BELIEVES THE DISCREPANCY WAS A POTENTIAL FALSE POSITIVE RESULT. TESTING OF RETAINED MATERIAL OF ARCHITECT (B)(4), WHICH IS IDENTICAL TO THE REAGENT (B)(4), MET SPECIFICATIONS; CONTROLS SHOWED VALUES WITHIN TYPICAL RANGE. TO EVALUATE THE SPECIFICITY OF THE REAGENT LOT ADDITIONAL 10 REPLICATES OF NEGATIVE CONTROL WERE TESTED. THE REAGENT KITS SHOWED NORMAL PERFORMANCE WITHOUT FALSE REACTIVE RESULTS, FAR AWAY FROM THE UPPER SPECIFICATION LIMIT. A REVIEW OF THE FINAL LOT APPROVAL AND RETAINED SAMPLE DATA SHOWED THAT THE NEGATIVE CONTROL AND POSITIVE CONTROLS ARE COMPARABLE AND WELL WITHIN THE SPECIFICATION RANGE. AS PART OF OUR EVALUATION WE HAVE REVIEWED THE COMPLAINT AND MANUFACTURING RECORDS THE REAGENT LOT IDENTIFIED IN THE CUSTOMERS COMPLAINT AND DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMERS OBSERVATION. WE HAVE NOT OBSERVED ANY UNUSUAL COMPLAINT ACTIVITY FOR THESE LOTS, TO DATE. THE ASSAY PERFORMANCE OF THE ARCHITECT (B)(4) ASSAY WAS REASSESSED WITH REGARDS TO SPECIFICITY WITHIN SIX INTERNAL QUALIFICATION PROJECTS IN (B)(4) 2006, (B)(4) 2006, (B)(4) 2007, (B)(4) 2007, (B)(4) 2008 AND (B)(4) 2008. AS A RESULT, THE PACKAGE INSERT CLAIM FOR SPECIFICITY COULD BE CONFIRMED ON RANDOM BLOOD DONORS (SERUM AND PLASMA). THE CURRENT REAGENT SHOWED COMPARABLE SPECIFICITY AS REFERENCED IN THE PACKAGE INSERT (99.89% SPECIFICITY ON SERUM AND PLASMA SAMPLES). THERE IS NO SPECIFIC EXPLANATION WHY THE CUSTOMER OBSERVED POTENTIAL FALSE REACTIVE RESULTS FOR THE PATIENT SAMPLE IN QUESTION, BUT AS WITH OTHER IMMUNOLOGICAL ASSAYS, FALSE REACTIVE RESULTS MAY OCCUR TO A CERTAIN EXTENT. THE TYPICAL FREQUENCY OF POTENTIAL FALSE REACTIVE PATIENT RESULTS WITH THIS ASSAY HAS BEEN ESTIMATED FROM TESTING OF A LARGE POPULATION AND IS STATED IN THE PACKAGE INSERT. IF SUPPLEMENTAL TESTING SHOWS INDETERMINATE OR NEGATIVE RESULTS, IT IS RECOMMENDED TO EVALUATE A FOLLOW-UP BLEED, DRAWN FROM THE PATIENT IN QUESTION, THREE TO SIX WEEKS LATER. INDIVIDUALS WHO ARE REPEATEDLY REACTIVE SHOULD BE REFERRED FOR MEDICAL EVALUATION AND TEST RESULTS MUST BE CORRELATED WITH CLINICAL SYMPTOMS AND OTHER SEROLOGICAL MARKERS. BASED ON OUR EVALUATION RESULTS, WE HAVE DETERMINED THAT ARCHITECT (B)(4) REAGENT, (B)(4), (B)(4)PERFORMED AS STATED WITHIN THE PACKAGE INSERT CLAIM FOR SPECIFICITY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE ARCHITECT I2000SR ANALYZER HAS GENERATED A DISCREPANT RESULT. IN 2009, A PATIENTS RESULT WAS NON-REACTIVE (S/CO 0.18). THE SAMPLE THEN HAD A SECONDARY ALIQUOT TUBE TESTED TWO DAYS LATER, AND THE RESULT WAS REACTIVE (S/CO 1.15). THE SECONDARY SAMPLE HAS BEEN RETESTED IN DUPLICATE AND THE RESULTS ARE BOTH REACTIVE (S/CO 7.16 AND S/CO 4.41). THE QC HAS BEEN IN RANGE. THE PRIMARY TUBE SAMPLE COULD NOT BE RETESTED DUE TO INSUFFICIENT VOLUME. THE ACCOUNT DOES NOT KNOW IF THE SAMPLE IS A FALSE REACTIVE OR A FALSE NON-REACTIVE RESULT AT THIS TIME. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HIV AG/AB COMBO FOR THE DETECTION OF HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES MZF ABBOTT GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER (B)(4)| (B)(6) REAGENT LIST UNKNOWN