BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS VARICELLA ZOSTER IGG

    MDR report key: 5004763 · Received August 14, 2015

    Report

    Report Number
    3002769706-2015-00070
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Report Date
    July 30, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFY
    PMA / PMN Number
    K923122
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION REPRODUCED THE RESULTS IDENTIFIED BY (B)(4) CUSTOMER VIA TESTING OF THE FIFTEEN (15) RETURNED SAMPLES WITH VIDAS® VARICELLA-ZOSTER IGG (VZG), BATCHES 1003869180 AND 1004002070. THE SAMPLE RESULTS WERE DETERMINED EQUIVOCAL OR NEGATIVE. THE ISSUE ENCOUNTERED BY THE CUSTOMER IS NOT LINKED WITH A SPECIFIC LOT. THIS ISSUE WAS PREVIOUSLY DOCUMENTED BASED ON THE RESULTS OF A COMPARISON STUDY WITH TWO OTHER COMPETITOR KITS. THE STUDY CONCLUDED THERE ARE DIFFERENCES BETWEEN THE THREE TECHNIQUES FOR LOWER LEVEL SAMPLES. A LARGE NUMBER OF EQUIVOCAL AND NEGATIVE RESULTS WERE OBSERVED WITH VIDAS® VARICELLA-ZOSTER IGG TEST. RESULTS OF THE STUDY (IN PARTICULAR THE RATIO OF EQUIVOCAL RESULTS) ARE UNDER CONSIDERATION FOR FUTURE VZG DEVELOPMENT. AS DESCRIBED IN THE PACKAGE INSERT, THERE IS A LARGE "EQUIVOCAL ZONE" ASSOCIATED WITH THE VIDAS® VARICELLA-ZOSTER IGG ASSAY. RESULTS WITHIN THE EQUIVOCAL ZONE ARE NOT CONSIDERED FALSE RESULTS BECAUSE THERE IS NO CHANGE OF THE SEROLOGICAL STATUS. EQUIVOCAL RESULTS SHOULD BE REPEATED WITH A FRESH SPECIMEN. IF IT IS IMPRACTICAL TO OBTAIN A FRESH SPECIMEN, THE ASSAY IS REPEATED WITH THE ORIGINAL SPECIMEN. IF THE SAMPLE REPEATS AS AN EQUIVOCAL, THE SAMPLE SHOULD BE TESTED VIA DIFFERENT METHOD. VIDAS® VARICELLA-ZOSTER IGG ASSAY ONLY DETECTS IGG AND IS INTENDED AS AN AID IN THE DETERMINATION OF IMMUNOLOGICAL EXPERIENCE WITH VARICELLA-ZOSTER VIRUS. IT'S PRIMARY USE IS FOR VACCINATION FOLLOW-UP AND IS NOT RECOMMENDED TO ISOLATE IGG SEROLOGY RESULTS FOR THE DIAGNOSIS OF VARICELLA-ZOSTER VIRUS (VZV) INFECTION. AS RECOMMENDED IN THE PACKAGE INSERT, IF A DEFINITIVE DETERMINATION OF VZV IMMUNITY IS REQUIRED, PATIENTS WITH NEGATIVE RESULTS SHOULD BE RETESTED BY A MORE SENSITIVE ASSAY. THE INVESTIGATION DETERMINED THE VIDAS® VARICELLA-ZOSTER IGG ASSAY IS PERFORMING WITHIN DEVELOPMENT SPECIFICATIONS IN ACCORDANCE WITH THE DEFINED NEGATIVE/EQUIVOCAL/POSITIVE ZONES.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2015 A CUSTOMER IN (B)(6) REPORTED FALSE A NEGATIVE AND BORDERLINE RESULT USING THE VIDAS VARICELLA-ZOSTER IGG KIT (REF. 30217, LOT 1004002070, EXPIRATION DATE 18-FEB-2016). THE CUSTOMER REPEATED THE BORDERLINE RESULT WITH AN ALTERNATE MICROPLATE METHOD (DYNEX DSX) AND OBTAINED A POSITIVE RESULT. THE CUSTOMER ALSO RETESTED THE NEGATIVE VIDAS VARICELLA IGG RESULT WITH THE DYNEX METHOD; POSITIVE RESULT WAS OBTAINED. THERE WAS NO REPORTED ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS INITIATED INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540692 VIDAS VARICELLA ZOSTER IGG VIDAS VARICELLA IGG ASSAY LFY BIOMERIEUX SA 1004002070

    Patients

    Seq Age Sex Outcome Treatment
    1