BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS VARICELLA-ZOSTER IGG

    MDR report key: 4901403 · Received July 9, 2015

    Report

    Report Number
    3002769706-2015-00055
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Report Date
    July 3, 2015
    Manufacturer
    BIOMÉRIEUX SA
    Product Code
    LFY
    PMA / PMN Number
    K923122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    10 POSITIVE OR EQUIVOCAL NEAR POSITIVITY SAMPLES WERE TESTED ON RETAIN SAMPLES FROM LOT 1003778670. THE 10 SAMPLES GAVE APPROPRIATE RESULTS AND ARE WITHIN SPECIFICATION. COMPARED TO THE QUALITY CONTROL RESULTS OBTAINED DURING LOT RELEASE, LOT 1003778670 HAS NOT CHANGED. IN CONCLUSION, THE INVESTIGATION SHOWED THAT THERE IS NO QUALITY DRIFT FOR LOT 1003778670 AND IS WITHIN PERFORMANCE SPECIFICATIONS AS DEFINED WITHIN THE PACKAGE INSERT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BIOMÉRIEUX A DISCREPANT RESULT ON THE VIDAS VZG TEST KIT. THE SAMPLE WAS COLLECTED FROM A PREGNANT WOMAN AND GAVE A NEGATIVE RESULT WHEN TESTED WITH THE VIDAS VZG KIT. THE SAMPLE WAS SENT TO THE LEEDS REFERENCE LABORATORY AND RETURNED A POSITIVE RESULT. THE PATIENT DID NOT RECEIVE ANY TREATMENT. THE TREATMENT DECISION WAS BASED ON THE REFERENCE LABORATORY TEST RESULTS. VIDAS VARICELLA-ZOSTER IGG (VZG) IS AN AUTOMATED QUALITATIVE TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS FAMILY, FOR THE DETECTION OF IGG ANTIBODIES TO VARICELLA ZOSTER VIRUS IN HUMAN SERUM USING THE ELFA (ENZYME LINKED FLUORESCENT ASSAY) TECHNIQUE. VIDAS VZG IS INTENDED AS AN AID IN THE DETERMINATION OF IMMUNOLOGICAL EXPERIENCE WITH VARICELLA ZOSTER VIRUS. AN INTERNAL INVESTIGATION HAS BEEN INITIATED WITHIN BIOMÉRIEUX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447887 VIDAS VARICELLA-ZOSTER IGG ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLAZOSTER, LFY BIOMÉRIEUX SA 1003778670

    Patients

    Seq Age Sex Outcome Treatment
    1