BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM CMV IGG REAGENT

    MDR report key: 2111883 · Received June 2, 2011

    Report

    Report Number
    1415939-2011-00165
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    June 23, 2010
    Report Date
    March 28, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THREE AXSYM INSTRUMENTS WERE CALIBRATED PER THE INSTRUCTIONS IN THE PACKAGE INSERT BY TESTING THE CALIBRATORS IN DUPLICATE WITH REAGENT LOT 92966M500. FOR EACH OF THE THREE RUNS, A SINGLE REPLICATE OF EACH LEVEL OF ABBOTT CONTROLS WAS TESTED PER THE PACKAGE INSERT FOR VALIDITY. FIVE REPLICATES OF EACH AXSYM CMV-G PANELS 1, 2 AND 3 WERE TESTED ACROSS ALL THREE INSTRUMENTS. THE ACCEPTANCE CRITERIA WERE MET. TRACKING AND TRENDING IDENTIFIED NO ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE INVESTIGATION, NO DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, (B)(4), THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN AXSYM ANALYZER GENERATED FALSE (B)(6) CMV IGG RESULTS FOR THREE SAMPLES DRAWN FROM THE SAME PATIENT OVER A PERIOD OF NINE MONTHS. AN ARCHITECT ANALYZER GENERATED (B)(6) CMV IGG RESULTS FOR THE SAME PATIENT. THE (B)(6) CMV IGG RESULTS WERE CONFIRMED BY A (B)(4). THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CMV IGG REAGENT FOR THE MEASUREMENT OF IGG ANTIBODIES TO CYTOMEGALOVIRUS LFZ ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM LN 7A83-85 (B)(4)| AXSYM LN 7A83-85 (B)(4)