BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 3053035 · Received April 11, 2013

    Report

    Report Number
    3008344661-2013-00018
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    P050051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07C18 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 01L82.

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, SPECIFICITY TESTING, A REVIEW OF MANUFACTURING RECORDS, AND A REVIEW OF LABELING. A REVIEW OF COMPLAINT TICKETS DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR ARCHITECT ANTI-HBS REAGENT 7C18-25, LOT 22285LF00. THERE IS ONLY THIS COMPLAINT FOR THIS LOT AND THE COMPLAINT TRENDING REPORT REVIEW SHOWED NO ADVERSE TREND OR NON STATISTICAL TRENDS. ANALYTICAL SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE REFERENCE LOT OF ARCHITECT ANTI-HBS, LN 7C18-25, LOT 22285LF00. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET, DEMONSTRATING THAT ARCHITECT ANTI-HBS REAGENT, LN 7C18-25, LOT 22285LF00 IS PERFORMING ACCEPTABLY. A REVIEW OF THE MANUFACTURING AND TESTING RECORDS FOR LOT 22285LF00 WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. A REVIEW OF THE TEXT IN THE COMPLAINT IDENTIFIED THAT AN ANTIGEN ADDITION TEST WAS PERFORMED BY THE CUSTOMER ON THE PATIENT SAMPLE AND SHOWED A REDUCTION IN THE ANTIGEN CONCENTRATION. THESE RESULTS DEMONSTRATED THAT (B)(6) WAS PRESENT IN THE PATIENT SAMPLE, SUPPORTING THE POSITIVE ARCHITECT ANTI-HBS RESULTS GENERATED. A REVIEW OF THE ARCHITECT ANTI-HBS REAGENT PACKAGE INSERT WAS PERFORMED WHICH STATES THAT IF THE (B)(6) RESULTS ARE INCONSISTENT WITH CLINICAL EVIDENCE, ADDITIONAL TESTING IS SUGGESTED TO CONFIRM THE RESULT. FOR DIAGNOSTIC PURPOSES, RESULTS SHOULD BE USED IN CONJUNCTION WITH PATIENT HISTORY AND OTHER (B)(6) MARKERS FOR DIAGNOSIS OF ACUTE, CHRONIC, OR RECOVERED INFECTION. BASED ON OUR EVALUATION WE HAVE DETERMINED THAT ARCHITECT ANTI-HBS REAGENT LN 7C18-25, LOT 22285LF00 IS PERFORMING ACCEPTABLY AND NO DEFICIENCY OR MALFUNCTION WAS IDENTIFIED. THE (B)(6) RESULTS GENERATED BY THE CUSTOMER APPEAR TO BE (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED REPEAT (B)(6) RESULTS ON ONE PATIENT SAMPLE COMPARED TO THREE OTHER METHODS. THE RESULTS PROVIDED: ARCHITECT ANTI-HBS RUN ON (B)(6) 2013 = (B)(6) AND REPEATED AS (B)(6) (GREATER THAN OR EQUAL TO (B)(6) = (B)(6)). THE PATIENT SAMPLE WAS AGAIN TESTED ON (B)(6) 2013 AS AN AUTO DILUTION AND GENERATED A RESULT OF (B)(6) . THE CUSTOMER THEN SENT THE PATIENT SAMPLE OUT TO ANOTHER FACILITY WHERE THE FOLLOWING TESTS WERE RUN: PHA METHOD = (B)(6), CLIA METHOD = (B)(6), IMMUNO CHROMATOGRAPHY = (B)(6). ALL CONTROLS WERE WITHIN RANGE. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155863 ARCHITECT ANTI-HBS LOM ABBOTT IRELAND 22285LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER,LIST # 03M74-01| SERIAL # (B)(4)| ARCHITECT I2000SR ANALYZER,LIST # 03M74-01| SERIAL # (B)(4)