BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HIV AG/AB COMBO

    MDR report key: 6030193 · Received October 14, 2016

    Report

    Report Number
    3002809144-2016-00087
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 22, 2016
    Report Date
    April 14, 2017
    Manufacturer
    ABBOTT GERMANY
    Product Code
    MZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 4J27 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2P36.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBTAINED A (B)(6) INITIAL RESULT WHEN TESTING A PATIENT SAMPLE WITH THE ARCHITECT (B)(6) AG/AB COMBO ASSAY. RETESTING OF THE SAMPLE GENERATED A (B)(6) RESULT. THE SAMPLE GAVE A (B)(6) RESULT ON WESTERN BLOT. LIAISON DIASORIN TESTING GAVE A (B)(6) RESULT FOR (B)(6) AB AND (B)(6) AG/AB, BUT A (B)(6) RESULT FOR (B)(6) AG. THERE WAS NO PATIENT SAMPLE AVAILABLE FOR THIS INVESTIGATION. SENSITIVITY TESTING WAS PERFORMED WITH A RETAINED REAGENT KIT OF LOT 66118LI00. THE CLINICAL SENSITIVITY OF THE LOT WAS EVALUATED BY TESTING TWO COMMERCIALLY AVAILABLE SEROCONVERSION PANELS ((B)(6)). THE SEROCONVERSION PANEL RESULTS WERE COMPARED TO ARCHITECT (B)(6) TEST RESULTS PROVIDED BY (B)(4). THE REAGENT DETECTED THE SAME BLEEDS AS (B)(6) FOR THE SEROCONVERSION PANELS, SHOWING THAT THE SENSITIVITY PERFORMANCE IS NOT AFFECTED. A REVIEW OF DATA FROM THE INSTRUMENT IN THE LABORATORY WAS PERFORMED AND NO IMPACT FOR THE COMPLAINT ISSUE WAS IDENTIFIED. A REVIEW OF COMPLAINTS FOR LOT 66118LI00 DID NOT IDENTIFY ANY ISSUES OR TRENDS. A REVIEW OF THE ARCHITECT (B)(6) AG/AB COMBO ASSAY PACKAGE INSERT ADEQUATELY ADDRESSES SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS. BASED ON THE INVESTIGATION, THE ARCHITECT (B)(6) AG/AB COMBO REAGENT, LOT 66118LI00, PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE THE DEVICE WAS NOT PERFORMING AS INTENDED, AND CONCLUSIONS CODE WAS CORRECTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED ) (B)(6) RESULTS ON ONE PATIENT. THE CUSTOMER WAS PERFORMING CORRELATION TESTING BETWEEN THE ARCHITECT AND THE DIASORIN METHOD AND THE FOLLOWING RESULTS WERE GENERATED: (B)(6) . THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682286 ARCHITECT HIV AG/AB COMBO HIV P24 ANTIGEN AND HIV-1/HIV-2 ANTIBODIES MZF ABBOTT GERMANY 66118LI00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER, LIST # 03M74-02| SERIAL # (B)(4)