BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGG ASSAY

    MDR report key: 8966612 · Received September 5, 2019

    Report

    Report Number
    8020790-2019-00052
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LFZ
    PMA / PMN Number
    K920661
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX PERFORMED AN INTERNAL INVESTIGATION. INSTRUMENT ISSUE WAS EXCLUDED AS QCV RESULTS CONFORMED TO SPECIFICATIONS. BIOMÉRIEUX ALSO PERFORMED INVESTIGATIONAL TESTING WITH VIDAS LYME IGG, LOT 1007040560/191112-0. THIS INCLUDED TESTING FOUR INTERNAL SERA AND THE RETURNED CUSTOMER SAMPLE. THE INTERNAL TESTING INCLUDED TWO NEGATIVE AND TWO LOW POSITIVE TESTS; ALL INTERNAL RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER SAMPLE ALSO OBTAINED A POSITIVE RESULT WHEN TESTED INTERNALLY. THE CUSTOMER SAMPLE WAS THEN RERUN WITH THE CMG IGG ASSAY, FIRST WITHOUT SAMPLE AND THEN WITHOUT SPR; BOTH RESULTS WERE NEGATIVE WITH A RESULT OF LESS THAN OR EQUAL TO 4 UA/ML, DUPLICATING THE CUSTOMER'S INITIAL DISCREPANT RESULT. THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE OF THE FALSE NEGATIVE RESULT WAS OPERATOR ERROR DUE TO ABSENCE OF SPR OR SAMPLE. ACCORDING THE ABOVE DATA , THE REAGENT VIDAS CMV IGG LOT 1007040560/ 191112-0 WAS WITHIN THE EXPECTED PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH THE VIDAS® CMV IGG 60 TESTS (REFERENCE 30204, LOT 1007040560). PRODUCT REFERENCE 30204 IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. THE U.S. SIMILAR PRODUCT IS REFERENCE 30204-01. ON (B)(6) 2019 , THE CUSTOMER PROVIDED BIOMÉRIEUX WITH INFORMATION REGARDING FALSE NEGATIVE RESULTS FOR A PATIENT SAMPLE. THE ORIGINAL RESULT WAS LESS THAN 4 UA/ML, THE SAMPLE WAS REPEATED AND A RESULT OF 44UA/ML WAS OBTAINED. THE CUSTOMER CONFIRMED THE INCORRECT TEST RESULT HAD NO ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH BUT DID NOTE A ONE DAY DELAY OF OBTAINING TEST RESULTS. PRODUCT REFERENCE 30204 IS NOT MARKETED, SOLD OR DISTRIBUTED IN THE UNITED STATES. THE U.S. SIMILAR PRODUCT IS REFERENCE 30204-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757633 VIDAS® CMV IGG ASSAY VIDAS® CMV IGG ASSAY LFZ BIOMERIEUX SA 1007040560

    Patients

    Seq Age Sex Outcome Treatment
    1