BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 2500156 · Received March 22, 2012

    Report

    Report Number
    3002809144-2012-00044
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Report Date
    March 8, 2012
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZO
    PMA / PMN Number
    P050042
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (NO CONSEQUENCES OR IMPACT TO PATIENT). (B)(4) - ((B)(6) RESULT) THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    EVALUATION: (B)(6) RESULT. A RETAINED KIT OF ARCHITECT ANTI-HCV REAGENT, LIST NUMBER 6C37-30, LOT NUMBER 07748LI00 WAS CALIBRATED AND THE CALIBRATION MET INSTRUMENT SPECIFICATIONS. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. TO EVALUATE ANALYTICAL SENSITIVITY, TWO SENSITIVITY PANELS (CORE ONLY PANEL (PANEL A) AND NS3 ONLY PANEL (PANEL B)) WERE TESTED. THE SENSITIVITY PANEL VALUES MET SPECIFICATIONS AND THE RESULTS WERE IN THE TYPICAL RANGE AND NO (B)(6) RESULTS WERE OBTAINED. IN ADDITION THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX HCV SEROCONVERSION PANELS HCV 9041 AND HCV 9045). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT ANTI-HCV TEST RESULTS PROVIDED BY ZEPTOMETRIX. REAGENT LOT 07748LI00 DETECTED THE SAME BLEEDS AS (B)(6) WITH COMPARABLE S/CO VALUES FOR THE SEROCONVERSION PANELS. BASED ON THIS DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE IS NOT ADVERSELY AFFECTED. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED RELATED TO THE CUSTOMER'S OBSERVATION. THE ARCHITECT ANTI-HCV REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT A POSSIBLE (B)(6) ARCHITECT ANTI-HCV RESULT ((B)(6)) WAS GENERATED. THE SAMPLE WAS TESTED ON ANOTHER ANALYZER AND A (B)(6) RESULT WAS GENERATED ((B)(6)). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HCV MZO ABBOTT GERMANY 07748LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 SN (B)(4)| SN (B)(4)| ARCHITECT I2000SR ANALYZER 3M74-01| ARCHITECT I2000SR ANALYZER 3M74-01