BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 3113600 · Received May 15, 2013

    Report

    Report Number
    3002809144-2013-00126
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    May 8, 2013
    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)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT ANTI-HCV, LIST 06C37, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., ARCHITECT ANTI-HCV, LIST 01L79. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, SPECIFICITY AND SENSITIVITY TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. A RETAINED KIT OF (B)(6) REAGENT LOT 23706LI00 WAS CALIBRATED, AND CALIBRATORS AND CONTROLS MET SPECIFICATIONS. TWO HUNDRED NINETY-NINE REPLICATES OF POSITIVE CONTROL ACROSS THREE INSTRUMENTS GENERATED CONTROL VALUES IN THE TYPICAL RANGE. SENSITIVITY PANELS WERE RUN AND MET SPECIFICATIONS. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TRENDS FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A (B)(6) RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED AN INITIAL (B)(6) RESULT OF (B)(6). THE SAMPLE WAS RECENTRIFUGED AND GENERATED A (B)(6) RESULT OF (B)(6). THE PATIENT HAD A HISTORY OF (B)(6) RESULTS. THE (B)(6) RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215571 ARCHITECT ANTI-HCV MZO ABBOTT GERMANY 23706LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER| LN 03M74-01 SN (B)(4)| LN 03M74-01 SN (B)(4)