BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® MUMPS IGG

    MDR report key: 5458127 · Received February 24, 2016

    Report

    Report Number
    3002769706-2016-00039
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Report Date
    February 8, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LJY
    PMA / PMN Number
    K293903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN UNITED STATES REPORTED DISCREPANT RESULTS BETWEEN VIDAS® MUMPS IGG (REF 30218) LOT 1004183650/160602-0 AND ANOTHER METHOD (QUEST). RESULTS OF THE BIOMÉRIEUX INTERNAL INVESTIGATION ARE AS FOLLOWS: NO OTHER COMPLAINT RELATED TO BAD CORRELATION HAS BEEN REGISTERED ON THE VIDAS® IGG LOT 1004183650/160602-0. THERE IS NO NONCONFORMITY LINKED TO THE CUSTOMER'S ANOMALY. THE ANALYSIS OF THE BATCH HISTORY RECORDS SHOWS NO ANOMALY DURING THE CONTROL PROCESS. FOUR (4) INTERNAL SAMPLES WERE TESTED (RETAINED VIDAS® IGG LOT 160602-0 AND RETAINED VIDAS® IGG LOT 161218-0). RESULTS FOR ALL FOUR (4) INTERNAL SAMPLES WERE WITHIN SPECIFICATIONS. THE ANALYSIS OF THE CONTROL CARDS FOR THE FOUR (4) INTERNAL SAMPLES SHOWS THAT THE VIDAS® IGG LOT 1004183650/160602-0 IS IN THE TREND OF THE OTHER BATCHES. THE CUSTOMER'S SAMPLE WAS TESTED ON THE RETAINED VIDAS® IGG LOT 160602-0 AND ON THE RETAINED VIDAS® IGG LOT 161218-0. THE RESULTS OBTAINED (LOW EQUIVOCAL) WERE THE SAME AS THE CUSTOMER'S RESULTS (LOW EQUIVOCAL AND HIGH NEGATIVE); HOWEVER, VIDAS® MUMPS IGG PERFORMANCE DOES NOT CLAIM 100% IN TERMS OF SPECIFICITY OR SENSITIVITY. WITHOUT THE QUEST PERFORMANCE DATA (SPECIFICITY/SENSITIVITY) AND THE LACK OF A THIRD TEST METHOD, IT IS THEREFORE NOT POSSIBLE TO DETERMINE WHICH RESULT IS CORRECT. IN CONCLUSION, A PRODUCT PROBLEM WAS NOT IDENTIFIED FOR VIDAS® MUMPS IGG LOT 1004183650/160602-0.

    Description of Event or Problem · 1

    A CUSTOMER IN UNITES STATES REPORTED A FALSE NEGATIVE RESULT WHILE USING; VIDAS MUMPS IGG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113333 VIDAS® MUMPS IGG VIDAS® MUMPS IGG LJY BIOMERIEUX SA 1004183650

    Patients

    Seq Age Sex Outcome Treatment
    1