BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS RUB IGG II 60 TESTS

    MDR report key: 10373349 · Received August 6, 2020

    Report

    Report Number
    8020790-2020-00071
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Report Date
    April 7, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LYR
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN LUXEMBOURG REGARDING A FALSE POSITIVE RESULT FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® RUB IGG TESTS (REF. 30221, LOT 1007944810) TESTED AT POSITION A3 OF THEIR VIDAS® INSTRUMENT. THE CUSTOMER¿S SAMPLES WAS NOT RETURNED FOR THE INVESTIGATION. FOUR (4) INTERNAL SAMPLES (2 WITH A POSITIVE TARGET, 1 WITH AN EQUIVOCAL TARGET AND 1 WITH A NEGATIVE TARGET) WERE TESTED ON VIDAS® 3 INSTRUMENT WITH THE BATCH VIDAS® RUBG II REF. 30221 LOT 1007944810 / 210303-0. ALL THE RESULTS WERE WITHIN ACCEPTABLE RANGE, AND WITHOUT ANY EVOLUTION OVER TIME COMPARED TO THE RESULTS OBSERVED BEFORE THE BATCH RELEASE. A NEGATIVE SAMPLE (TARGET AT 3 IU / ML) WAS TESTED IN REPEATABILITY NINE (9) TIMES ON A VIDAS® 3 INSTRUMENT. ALL THE RESULTS OBTAINED WERE NEGATIVE WITH VALUES BETWEEN 2 AND 3 IU / ML. ADDITIONAL REPEATABILITY TESTING WAS CONDUCTED ON AN INTERNAL NEGATIVE SAMPLE TESTED 90 TIMES ON VIDAS® RUB IGG II LOT 1007944810 / 210303-0 KITS RETRIEVED FROM THE CUSTOMER'S SITE. ALL THE RESULTS OBSERVED WERE NEGATIVE AS EXPECTED. THERE WERE NO ANOMALIES DETECTED IN THE INSTRUMENT LOGS OF LOT 1007944810 THAT COULD EXPLAIN THE POSITIVE VIDAS® RUB IGG II RESULT OBSERVED ON POSITION A3. WITHOUT ANY PATIENT SAMPLE AVAILABLE, BIOMÉRIEUX CANNOT PURSUE FURTHER THE INVESTIGATION. THE ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED. THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® RUBG II REF. 30221 LOT 1007944810 / 210303-0.

    Description of Event or Problem · 1

    NOTE: REFERENCE 30221 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30226. A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE RESULT FOR A PATIENT SAMPLE IN ASSOCIATION WITH THE VIDAS® RUB IGG TESTS (REF. 30221, LOT 1007944810) TESTED AT POSITION A3 OF THEIR VIDAS® INSTRUMENT. THE CUSTOMER STATED THE PATIENT SAMPLE, ID (B)(6), WAS TESTED IN TWELVE (12) COMPARTMENTS OF THE VIDAS® 3 INSTRUMENT AND OBTAINED A NEGATIVE RESULT BETWEEN 3 AND 4 UI/ML FOR ELEVEN (11) OF THE TESTS. ONE TEST AT POSITON A3 OBTAINED A POSITIVE RESULT OF 16 UI/ML. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837790 VIDAS RUB IGG II 60 TESTS VIDAS® RUB IGG II 60 TESTS LYR BIOMERIEUX SA 1007944810

    Patients

    Seq Age Sex Outcome Treatment
    1