BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS CMV IGG

    MDR report key: 6180566 · Received December 16, 2016

    Report

    Report Number
    3002769706-2016-00520
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 24, 2016
    Report Date
    November 24, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFZ
    PMA / PMN Number
    K920661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS® CMV IGG. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE ANALYSIS OF THE QUALITY AND BATCH RECORDS FOR VIDAS® CMV IGG LOT 1005099130/170705-0 SHOWED NO OTHER COMPLAINTS, ISSUES OR NONCONFORMITIES IN ASSOCIATION WITH THE LOT. A TEST WAS CONDUCTED FOR 8 INTERNAL SAMPLES ON VIDAS® CMV IGG LOT 1005099130/170705-0. ALL SAMPLES CONFORMED TO THE EXPECTED RESULTS AND SPECIFICATIONS. A REVIEW OF QUALITY CONTROL RECORDS ON SEVERAL BATCHES OF VIDAS® CMV IGG SHOWED ALL SAMPLES ARE WITHIN THE EXPECTED RANGES, AND LOT 170705-0 IS IN THE TREND AS THE OTHER LOTS. THE INSTRUCTIONS FOR USE (PACKAGE INSERT) INDICATE THE FOLLOWING: -IT IS RECOMMENDED TO CONFIRM EQUIVOCAL RESULTS USING A SECOND SAMPLE. -THE VIDAS® CMVG ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO ACCOUNT THE CLINICAL SYMPTOMS AND THE MEDICAL ANALYSIS RESULTS FROM OTHER TESTS (E.G. DETECTION OF ANTI-CMV IGM IN CASE OF PRIMARY INFECTION). THE INVESTIGATION CONCLUDED THE VIDAS® MV IGG LOT 1005099130/170705-0 PERFORMED AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH THE VIDAS® CMV IGG. THE CUSTOMER REPORTED THAT ON (B)(6) 2016, THEY OBSERVED A QUALITY CONTROL (QC) OUT OF RANGE WHEN USING THE VIDAS® CMV IGG. FOLLOWING THIS, THE CUSTOMER TESTED A KNOWN POSITIVE PATIENT SERUM SAMPLE. THE RESULT SHIFTED FROM POSITIVE TO EQUIVOCAL. PATIENT SAMPLE: TEST 1 - RESULT 8UA/ML POSITIVE; TEST 2 - RESULT 5 UA/ML EQUIVOCAL. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830813 VIDAS CMV IGG VIDAS CMV IGG LFZ BIOMERIEUX SA 1005099130

    Patients

    Seq Age Sex Outcome Treatment
    1