BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 8702591 · Received June 16, 2019

    Report

    Report Number
    8020790-2019-00032
    Event Type
    Malfunction
    Date Received
    June 16, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A CUSTOMER REPORT OF FALSE NEGATIVE RESULTS WITH VIDAS® CMV IGM (1007040660 / 191112-0) WHEN COMPARING INTER-LABORATORY RESULTS, FOR A QUALITY CONTROL TEST FROM THE INSTITUTE RFB. BIOMÉRIEUX PERFORMED INVESTIGATION TESTING WHICH INCLUDED TESTING THREE (3) INTERNAL NATURAL SERA, TWO (2) KNOWN POSITIVE QC SAMPLES AND QC RFB SAMPLE . ALL INVESTIGATIONAL ASSAYS WERE PERFORMED ON THREE DIFFERENT CMV IGM LOTS INCLUDING LOT 1007040660 / 191112-0. ALL INTERNAL AND QC SAMPLES OBTAINED RESULTS THAT WERE WITHIN SPECIFICATION. BIOMÉRIEUX DID OBTAIN A NEGATIVE RESULT FOR THE QC RFB SAMPLE ACROSS ALL THREE CMV IGM LOTS. BIOMÉRIEUX OBTAINED COMPLEMENTARY INFORMATION ABOUT THE RFB ORGANISM, WHICH CONFIRMED THE NATURE OF THIS SAMPLE IS CITRATE PLASMA SAMPLE. CITRATE PLASMA IS NOT VALIDATED FOR VIDAS CMV IGM . AS INDICATED IN THE PACKAGE INSERT FOR VIDAS CMV IGM REF. 30205 : " SPECIMEN TYPE AND COLLECTION : HUMAN SERUM" IS THE ONLY KIND OF SAMPLE VALIDATED BY BIOMÉRIEUX FOR THE TEST. VIDAS CMV IGM LOT 1007040660 / 191112-0 PERFORMED AS EXPECTED. CORRECTED DATA: THE INITIAL REPORTING OF THIS EVENT WAS FOR LOT 1006946280. NEW INFORMATION CONFIRMED THAT THE IMPACTED LOT NUMBER WAS 1007040660. D4: UPDATED LOT: 1007040660 D4: UPDATED EXPIRATION DATE: 12-NOV-2019 H4: UPDATED DATE OF MANUFACTURE: 11-JAN-2019.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE NEGATIVE RESULTS WITH VIDAS® CMV IGM (LOT1006946280) WHEN COMPARING INTER-LABORATORY RESULTS, FOR A QUALITY CONTROL TEST FROM THE INSTITUTE RFB. FOUR (4) SAMPLES WERE USED: SAMPLE 1: NEGATIVE CONTROL, SAMPLE 2: PATIENT WITH ACUTE CMV INFECTION, SAMPLE 3: PATIENT WITH PAST CMV INFECTION, SAMPLE 4: PATIENT WITH PAST CMV INFECTION. THE RESULTS OF THE SAMPLES 1, 3 AND 4 WERE CORRECT FOR ALL SISTER LABS, HOWEVER SAMPLE 2 RESULTS WERE FALSE NEGATIVE FOR THREE LABS AND CORRECT FOR ONE LAB. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS A QUALITY CONTROL TEST. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495991 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 1007040660

    Patients

    Seq Age Sex Outcome Treatment
    1