BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 3173116 · Received June 17, 2013

    Report

    Report Number
    3002809144-2013-00137
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 31, 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

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. TICKET SEARCHES DETERMINED THAT THERE IS NO ATYPICAL COMPLAINT ACTIVITY FOR THE LIKELY CAUSE LOTS AND THE 12 MONTH TRACKING AND TRENDING REPORT REVIEW DETERMINED THAT THERE ARE NO ADVERSE TRENDS FOR THE COMPLAINT ISSUE. A RETAINED REAGENT KIT OF ARCHITECT ANTI-HCV REAGENT, (B)(4), LOT NUMBER 25043LI00 WAS CALIBRATED AND THE CALIBRATIONS MET INSTRUMENT SPECIFICATIONS. ALL CONTROL VALUES MET CONTROL SPECIFICATIONS AND WERE IN THE TYPICAL RANGE. THE ANALYTICAL SENSITIVITY WAS EVALUATED AND THE SENSITIVITY PANEL VALUES MET SPECIFICATIONS. RESULTS WERE ALL IN THE TYPICAL RANGE AND NO FALSE NON-REACTIVE RESULTS WERE OBTAINED. IN ADDITION, THE CLINICAL SENSITIVITY WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SERO-CONVERSION PANELS. THE REAGENT DETECTED THE SAME BLEEDS AS REACTIVE WITH COMPARABLE S/CO VALUES FOR THE SERO-CONVERSION PANELS. BASED ON THIS DATA IT WAS SHOWN THAT THE SENSITIVITY PERFORMANCE IS NOT ADVERSELY AFFECTED. TO EVALUATE ERRATIC RESULTS, 300 REPLICATES OF POSITIVE CONTROL WERE TESTED ACROSS THREE INSTRUMENTS. ALL POSITIVE CONTROL VALUES MET CONTROL SPECIFICATIONS AND NO FALSE NON-REACTIVE RESULTS WERE IDENTIFIED. BASED ON THE EVALUATION RESULTS, NO MALFUNCTION OR PRODUCT DEFICIENCY IDENTIFIED AND THE PRODUCT IN QUESTION IS PERFORMING AS INTENDED.

    Additional Manufacturer Narrative · 1

    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 06C37 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01L79. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED (B)(6) RESULT FOR THE ARCHITECT ANTI-HCV ASSAY. THE SAME PATIENT SAMPLE WAS RETESTED (AS THE PATIENT HAD A PREVIOUS (B)(6) RESULT) AND (B)(6) RESULTS WERE GENERATED. THE (B)(6) RESULT WAS REPORTED OUT AND THE CUSTOMER QUESTIONED THE (B)(6) RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273157 ARCHITECT ANTI-HCV MZO ABBOTT GERMANY 25043LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 03M74-01, SN (B)(4)| ARCHITECT I2000 03M74-01, SN (B)(4)