BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MUMPS IGG ASSAY

    MDR report key: 5365053 · Received January 13, 2016

    Report

    Report Number
    3002769706-2016-00009
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Report Date
    October 16, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJY
    PMA / PMN Number
    K923903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INTERNAL INVESTIGATION WAS CONDUCTED. HOWEVER, THE CUSTOMER DID NOT COMPLY WITH BIOMÉRIEUX REQUEST FOR SAMPLE SUBMITTAL AND THE REFERENCED PRODUCT LOT WAS ALREADY EXPIRED. ANALYSIS OF THE MANUFACTURING QC BATCH RECORD FOR THE REFERENCED LOT INDICATED NO ABNORMALITY. AS INDICATED IN THE INSTRUCTIONS FOR USE, VIDAS MUMPS IGG PERFORMANCE DOES NOT CLAIM 100% IN TERM OF SPECIFICITY OR SENSITIVITY. VIDAS MUMPS IGG AND ARUP USE DIFFERENT TESTING METHODS; THEY ARE QUALITATIVE ELFA TEST AND SEMI-QUANTITATIVE CHEMILUMINESCENT TEST, RESPECTIVELY. WITHOUT THE ARUP PERFORMANCE SPECIFICATIONS (SENSITIVITY AND SPECIFICITY) AND THE LACK OF THIRD CONFIRMATORY METHOD, IT IS NOT POSSIBLE TO DETERMINE WHICH RESULT IS CORRECT. THE INVESTIGATION CONCLUDED THAT NO PRODUCT PERFORMANCE ISSUE WAS CONFIRMED FOR THE REFERENCED LOT OF VIDAS MUMPS IGG ASSAY.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A DISCREPANCY IN RESULTS WITH THE VIDAS MUMPS IGG TEST. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL TO BIOMERIEUX THAT THE RESULTS LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. SUBMITTAL OF THE PATIENT SAMPLE HAS BEEN REQUESTED. BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21287 VIDAS® MUMPS IGG ASSAY VIDAS® MUMPS IGG ASSAY LJY BIOMERIEUX SA 1003330330

    Patients

    Seq Age Sex Outcome Treatment
    1