BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV REAGENT

    MDR report key: 1379776 · Received May 13, 2009

    Report

    Report Number
    2623532-2009-00063
    Event Type
    Malfunction
    Date Received
    May 13, 2009
    Report Date
    September 26, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LATE MDR IS A RETROSPECTIVE FILING. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US. ADDENDUM INVESTIGATION: A RETURNED CUSTOMER REAGENT KIT AND BLOOD DONOR SAMPLE WAS RECEIVED AFTER COMPLETION OF THE ORIGINAL COMPLAINT INVESTIGATION. AN ADDITIONAL INVESTIGATION WAS PERFORMED USING THE RETURN MATERIAL. THE INVESTIGATION TEAM TESTED THE RETURNED SPECIMEN SAMPLE WITH A RETAINED SAMPLE (REAGENT KIT STORED AT ABBOTT LABORATORIES) OF ARCHITECT ANTI-HCV, LOT NUMBER 48237HN00 AS THE COMPLAINT LOT NUMBER 48481HN00 WAS ALREADY EXPIRED WHEN THE TICKET WAS OPENED. ONE REPLICATE OF THE NEGATIVE CONTROL AND POSITIVE CONTROL AND THREE REPLICATES OF THE SAMPLE WERE TESTED. THE CONTROL VALUES WERE WITHIN THE SPECIFICATION RANGES STATED IN THE RESPECTIVE PACKAGE INSERT. CONCORDANTLY WITH THE CUSTOMER'S OBSERVATION THE RETURNED BLOOD DONOR SAMPLE WAS TESTED REACTIVE AT THE INVESTIGATION SITE. FURTHERMORE, THE SAMPLE WAS TESTED WITH CHIRON RIBA HCV 3.0 SIA AND INNOGENETICS INNO-LIA HCV. TEST RESULT OF THE PATIENT SAMPLE ON CHIRON RIBA HCV 3.0 SIA WAS INTERPRETED AS INDETERMINATE ACCORDING TO THE RESPECTIVE PACKAGE INSERT. HOWEVER A CLEARLY VISIBLE C33C BAND WAS DETECTABLE IN THE SAMPLE. THIS SIGNAL INDICATES FOR THE PRESENCE OF ANTIBODIES AGAINST HCV. ADDITIONALLY, TESTING WITH THE INNOGENETICS INNO-LIA HCV OBTAINED AN HCV-POSITIVE TEST RESULT ACCORDING TO PACKAGE INSERT INTERPRETATION. ON THE BASIS OF THIS TEST RESULTS THE BLOOD SAMPLE IS CATEGORIZED AS "NOT FALSE REACTIVE" FOR ARCHITECT ANTI-HCV, LOT NUMBER 48481HN00. NEVERTHELESS, FOR DIAGNOSTIC PURPOSES, ALL PATIENT RESULTS OBTAINED WITH ARCHITECT ANTI-HCV SHOULD BE USED IN CONJUNCTION WITH PATIENT HISTORY AND OTHER HEPATITIS MARKERS FOR DIAGNOSIS OF ACUTE OR CHRONIC INFECTION. BASED ON OUR PREVIOUS AND PRESENT INVESTIGATION, IT IS DETERMINED THAT ARCHITECT ANTI-HCV, LOT NUMBER 48481HN00, IDENTIFIED IN THIS COMPLAINT, WAS PERFORMING ACCEPTABLY. ORIGINAL INVESTIGATION: IN ORDER TO ASSESS THE SPECIFICITY OF THIS COMPLAINT LOT, THE INVESTIGATION TEAM REVIEWED RETAINED SAMPLE (REAGENT KIT STORED AT ABBOTT LABORATORIES) OF ARCHITECT ANTI-HCV REAGENT KIT, LOT NUMBER 48480HN00 (CONTAINING THE SAME MATERIAL AS LOT NUMBER 48481HN00). ONE REPLICATE OF THE NEGATIVE CONTROL, POSITIVE CONTROL AND ADDITIONALLY 3 REPLICATES OF A SECOND LOT NEGATIVE CONTROL WERE TESTED WITH EACH LOT NUMBER. THE CONTROL VALUES ARE WITHIN THE SPECIFICATION RANGES STATED IN THE RESPECTIVE PACKAGE INSERT. FOR EACH SINGLE REPLICATE OF THE SECOND LOT OF NEGATIVE CONTROL, THE S/CO VALUES ARE CALCULATED AND NON-REACTIVE RESULTS ARE OBTAINED FOR THE TESTED REAGENT KIT. AS PART OF THIS INVESTIGATION REVIEW WAS PERFORMED OF OUR MANUFACTURING RECORDS FOR LOT NUMBER 48481HN00. DURING FINAL LOT RELEASE, THE REAGENT KIT SPECIFICITY TESTING INCLUDES A PANEL OF 105 NEGATIVE SPECIMENS. A REVIEW OF THIS NEGATIVE POPULATION TESTING PERFORMED FOR FINAL RELEASE TESTING DID NOT INDICATE A SPECIFICITY ISSUE FOR THIS LOT. NO CALIBRATION FAILURE OCCURRED DURING FINAL RELEASE TESTING OR DURING TESTING FOR THIS INVESTIGATION. WE CANNOT PROVIDE A SPECIFIC REASON WHY THE CUSTOMER EXPERIENCED THIS PROBLEM BUT HAVE EVALUATED THE CUSTOMER OBSERVATION TOGETHER WITH OTHER PERFORMANCE FEEDBACK AND VERIFIED THAT THE PRODUCT IS CURRENTLY CONTINUING TO MEET PERFORMANCE SPECIFICATIONS FOR SPECIFICITY. RECOMMENDATIONS ARE AS FOLLOWS: SEPTUMS MUST BE USED TO PREVENT REAGENT EVAPORATION AND CONTAMINATION, AND TO ENSURE REAGENT INTEGRITY. RELIABILITY OF ASSAY RESULTS CANNOT BE GUARANTEED IF SEPTUMS ARE NOT USED ACCORDING TO THE INSTRUCTIONS IN THIS PACKAGE INSERT. TO AVOID CONTAMINATION, WEAR CLEAN GLOVES WHEN PLACING A SEPTUM ON AN UNCAPPED REAGENT BOTTLE. WHEN HANDLING CONJUGATE VIALS, CHANGE GLOVES THAT HAVE CONTACTED HUMAN PLASMA/SERA, SINCE INTRODUCTION OF HUMAN IGG/IGM WILL RESULT IN A NEUTRALIZED CONJUGATE. ONCE A SEPTUM HAS BEEN PLACED ON AN OPEN REAGENT BOTTLE, DO NOT INVERT THE BOTTLE AS THIS WILL RESULT IN REAGENT LEAKAGE AND MAY COMPROMISE ASSAY RESULTS. ALL INITIALLY REACTIVE SPECIMENS SHOULD BE RETESTED IN DUPLICATE. IF BOTH RETEST VALUES ARE NONREACTIVE, THE SPECIMEN MUST BE CONSIDERED NONREACTIVE FOR ANTI-HCV. IF EITHER OF THE RETEST VALUES IS REACTIVE, THE SPECIMEN MUST BE CONSIDERED REPEATEDLY REACTIVE FOR ANTI-HCV BY THE CRITERIA OF ARCHITECT ANTI-HCV. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THIS LATE MDR IS A RETROSPECTIVE FILING FOR AN INTERNATIONAL PRODUCT WITH A SIMILAR US PRODUCT. THE ACCOUNT STATED A BLOOD DONOR GENERATED DISCREPANT ARCHITECT ANTI-HCV RESULTS. THE ARCHITECT ANTI-HCV REAGENT BOTTLE 1 GENERATED A REACTIVE RESULT. THE ACCOUNT TRIED TO RECALIBRATE THE ASSAY USING THE SAME REAGENT, BUT THE CALIBRATION FAILED. A NEW REAGENT OF ARCHITECT ANTI-HCV WAS OPENED AND THE PATIENT TESTED NEGATIVE. A SECOND SPECIMEN WAS OBTAINED FROM THE SAME PATIENT AND AGAIN ARCHITECT ANTI-HCV REAGENT BOTTLE 1 GENERATED A REACTIVE RESULT, BUT THE NEW REAGENT GENERATED A NONREACTIVE RESULT. THE DONOR SPECIMENS WERE SENT FOR CONFIRMATORY TESTING. NO ARCHITECT ANTI-HCV RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HCV REAGENT FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS C VIRUS MZO ABBOTT DIAGNOSTICS INT'L, LTD 48481HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR ARCHITECT