BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS HCG

    MDR report key: 10907491 · Received November 26, 2020

    Report

    Report Number
    8020790-2020-00127
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JLW
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX THAT THEY OBSERVED OUT OF RANGE HIGH RESULTS WHEN USING VIDAS® HCG 60 TESTS (REF. 30405, LOT 1008107910), IN THE CONTEXT OF AN EXTERNAL QUALITY CONTROL. AS THIS WAS AN EXTERNAL QUALITY CONTROL SAMPLE, THERE IS NO PATIENT INVOLVED. THE CUSTOMER OBTAINED THE FOLLOWING RESULTS WHEN TESTING THE LIQUICHEK IMMUNOASSAY PLUS CONTROL BIO-RAD, LEVEL 1 WITH VIDAS HCG 60 TESTS, LOT 1008107910: ON (B)(6) 2020: 5.39 MUI/ML. ON (B)(6) 2020: 5.55 MUI/ML, 6.29 MUI/ML, 6.07 MUI/ML, 5.35 MUI/ML, 6.02 MUI/ML. ON (B)(6) 2020: 5.13 MUI/ML. THE EXPECTED RANGE FOR THIS QC SAMPLE LEVEL 1 WAS 4.23 (3.51 - 4.949) RILIBÄK RANGE (17% DEVIATION). IT IS REPORTED THAT CALIBRATIONS PERFORMED ON (B)(6) 2020 AND ON (B)(6) 2020 WERE VALID. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 30405 IS NOT REGISTERED IN THE UNITED STATES. THE U.S SIMILAR DEVICE IS PRODUCT REFERENCE 30405-01 (K141133).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377463 VIDAS HCG VIDAS® HCG JLW BIOMERIEUX SA 1008107910

    Patients

    Seq Age Sex Outcome Treatment
    1