BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGG

    MDR report key: 8350673 · Received February 19, 2019

    Report

    Report Number
    8020790-2019-00014
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Report Date
    April 17, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFZ
    UDI-DI
    03573026156831
    PMA / PMN Number
    K920661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN THE UNITED STATES REPORTED A FALSE POSITIVE RESULT FOR A CAP SURVEY SAMPLE (SURVEY VR3-B2018, SAMPLE VR3-09) IN ASSOCIATION WITH THE VIDAS® CMV (CYTOMEGALOVIRUS) IGG ASSAY (REFERENCE 30204-01 LOT 1006388970). THE CUSTOMER REPORTED THAT CMV IGG ANTIBODIES WERE PRESENT. THEIR POSITIVE RESULT WAS 7UA/ML. THE EXPECTED RESULT WAS CMV IGG ANTIBODIES NOT PRESENT (NEGATIVE). BIOMÉRIEUX INITIATED AN INVESTIGATION WHICH INCLUDED A REVIEW OF APPLICABLE COMPLAINTS AND QUALITY CONTROL RECORDS, REVIEW OF CAP SURVEY REPORT AS WELL AS INTERNAL TESTING. THE DOCUMENTATION REVIEW SHOWED NO INDICATION OF A TREND NOR ANY ANOMALIES ASSOCIATED WITH THE MANUFACTURING OR PACKAGING PROCESSES FOR LOT 1006388970. QUALITY CONTROL SAMPLE VR3-9 WAS TESTED ON FOUR VIDAS CMV IGG BATCHES. BATCH 1006388970 WAS NOT TESTED AS THIS LOT HAD EXPIRED PRIOR TO INVESTIGATIONAL TESTING. ALL THE RESULTS WERE EQUIVOCAL WITH A CONCENTRATION OF 5 UA/ML. A REVIEW OF THE CAP SURVEY REPORT SHOWED THAT THIS SURVEY SAMPLE IS CMV IGM POSITIVE. ADDITIONALLY, CLSI GUIDELINE EP14-A3 STATES THAT PROCESSED SAMPLES USED AS QC MATERIAL (E.G EQA) CAN HAVE MATRIX EFFECT. TO CONCLUDE, VIDAS CMV IGG PRODUCT REF 30204 IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A (B)(6) RESULT FOR A (B)(6) SURVEY 2018 (B)(6) SAMPLE (B)(6) IN ASSOCIATION WITH THE VIDAS® CMV IGG ASSAY. THE CUSTOMER TWICE OBTAINED A (B)(6) RESULT, WHEN THE EXPECTED RESULT WAS (B)(6). THERE WAS NO PATIENT INVOLVEMENT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142314 VIDAS® CMV IGG VIDAS® CMV IGG LFZ BIOMERIEUX SA 1006388970 03573026156831

    Patients

    Seq Age Sex Outcome Treatment
    1