BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS CMV IGM 30 TESTS

    MDR report key: 11440037 · Received March 8, 2021

    Report

    Report Number
    8020790-2021-00025
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Report Date
    April 7, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ITALY REGARDING UNDERESTIMATED RESULTS IN ASSOCIATION WITH THE VIDAS® CMV IGM 30 TESTS (REF 30205, BATCH 1008182270) WHEN TESTING AN EXTERNAL QUALITY CONTROL SAMPLE. THE CUSTOMER HAS NOT PROVIDED THE VALUE OBTAINED OR UNITS OF THE UNDERESTIMATED RESULT BUT CONFIRMED IT WAS UNDERESTIMATED COMPARED TO THE EXPECTED RESULT. THE EXPECTED RESULT WAS ALSO NOT PROVIDED. THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT HIGHLIGHT ANY ISSUES DURING MANUFACTURING FOR VIDAS® CMV IGM LOT 1008182270 / 210526-0. THE CUSTOMER¿S SAMPLE WAS NOT AVAILABLE TO PERFORM INVESTIGATIONAL TESTING. THREE (3) INTERNAL SAMPLES WITH THE TARGETS AT 0.69, 0.99 AND 2.08 TV WERE TESTED ON THE RETAIN KIT OF VIDAS® CMV IGM LOT 1008182270 / 210526-0 BY THE COMPLAINTS LABORATORY. ALL THE RESULTS WERE WITHIN SPECIFICATIONS AND HAD NO SIGNIFICANT DIFFERENCE COMPARED TO THE RESULTS OBSERVED BEFORE THE BATCH WAS RELEASED. THE INVESTIGATION DID NOT IDENTIFY ANY OBVIOUS ROOT CAUSE TO THE CUSTOMER¿S COMPLAINT. WITHOUT THE CUSTOMER'S RETURN SAMPLE AND KIT, BIOMÉRIEUX CANNOT PURSUE INVESTIGATION. THERE IS NO RECONSIDERATION OF PERFORMANCE FOR VIDAS® CMV IGM REF 30205 LOT 1008182270 / 210526-0.SEE SECTION H10.

    Description of Event or Problem · 1

    NOTE: PRODUCT REFERENCE 30205 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE (B)(4). A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF UNDERESTIMATED RESULTS IN ASSOCIATION WITH THE VIDAS® CMV IGM 30 TESTS (REF 30205, BATCH 1008182270) WHEN TESTING AN EXTERNAL QUALITY CONTROL SAMPLE. THE CUSTOMER HAS NOT PROVIDED THE VALUE OBTAINED OR UNITS OF THE UNDERESTIMATED RESULT BUT CONFIRMED IT WAS UNDERESTIMATED COMPARED TO THE EXPECTED RESULT. THE EXPECTED RESULT WAS ALSO NOT PROVIDED. THERE IS NO ADVERSE PATIENT IMPACT. ALTHOUGH UNDERESTIMATED RESULTS WERE OBTAINED WHEN TESTING THIS QC SAMPLE, THE CUSTOMER CONFIRMED THEY HAVE NOT OBTAINED UNDERESTIMATED RESULTS FOR ANY PATIENT SAMPLES. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338253 VIDAS CMV IGM 30 TESTS VIDAS® CMV IGM 30 TESTS LKQ BIOMERIEUX SA 1008182270

    Patients

    Seq Age Sex Outcome Treatment
    1