BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 4960051 · Received August 3, 2015

    Report

    Report Number
    3002809144-2015-00054
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 14, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN-PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL FROM THE CUSTOMER WAS NOT AVAILABLE. A SENSITIVITY TESTING PROTOCOL WAS EXECUTED USING LOT 50043LI00. TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. NO ISSUES WERE IDENTIFIED WHICH WOULD INDICATE A PRODUCT DEFICIENCY FROM THE BATCH RECORD REVIEW. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT ANTI-HCV REAGENT LIST NUMBER 06C37, LOT NUMBER 50043LI00, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ANTI-(B)(6) RESULT WHILE USING THE ARCHITECT ANTI-(B)(6) ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA: ON (B)(6) 2015: INITIAL RESULT OF 1.05 S/CO, RETEST RESULT OF 1.04 S/CO. THIS PATIENT HAD UNDERGONE A DRIP TREATMENT, NOT RELATED TO HCV AND WHEN THE PATIENT WAS RETESTED THE NEXT DAY THE HCV RESULTS WERE LOWER THAN EXPECTED. ON (B)(6) 2015: INITIAL 0.71 S/CO, RETEST 0.73 S/CO. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505294 ARCHITECT ANTI-HCV ANTI-HCV MZO ABBOTT GERMANY 50043LI00

    Patients

    Seq Age Sex Outcome Treatment
    1