BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 4992007 · Received August 11, 2015

    Report

    Report Number
    3002809144-2015-00055
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Report Date
    September 10, 2015
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT SAMPLE OR REAGENT WAS PROVIDED FOR INVESTIGATION. A RETAINED REAGENT KIT OF ARCHITECT (B)(6) LOT 51201LI00 WAS TESTED IN A (B)(6) SETUP INCLUDING TESTING OF TWO (B)(6)PANELS (CORE ONLY PANEL AND NS3 ONLY PANEL), A (B)(6) PANEL AND TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS (ZEPTOMETRIX (B)(6)). RESULTS OF THIS SETUP DID NOT IMPLICATE THAT THE (B)(6) PERFORMANCE OF THE LOT IS (B)(6) IMPACTED. THE REAGENT KIT SHOWED NORMAL PERFORMANCE WITHOUT (B)(6) RESULTS. IN ADDITION A REVIEW FOR NON-CONFORMANCES AND DEVIATIONS ASSOCIATED WITH THE (B)(6) REAGENT LOT WAS PERFORMED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE OR NON-STATISTICAL TRENDS WERE IDENTIFIED. THE ARCHITECT (B)(6) REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C37 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L79. (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A (B)(6) RESULT OF 0.03 S/CO WAS GENERATED. PCR TESTING WAS PERFORMED AND A (B)(6) RESULT OF 5.8 WAS GENERATED. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525133 ARCHITECT ANTI-HCV ANTI-HCV MZO ABBOTT GERMANY 51201LI00

    Patients

    Seq Age Sex Outcome Treatment
    1