BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® LYME IGM ASSAY

    MDR report key: 5105564 · Received September 25, 2015

    Report

    Report Number
    3002769706-2015-00103
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Report Date
    September 4, 2015
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LSR
    PMA / PMN Number
    K943812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS PERFORMED. EVALUATION OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUE WITH VIDAS® LYME IGM REF. (B)(4) LOT 1004058460/160506-0 THE ON-SITE INVESTIGATION BY THE LOCAL FIELD SERVICE ENGINEER (FSE) ON (B)(6)2015 DID NOT IDENTIFY ANY ANOMALY WITH THE INSTRUMENT EXCEPT A PIECE OF PLASTIC, LIKELY FROM A SPR, INSIDE THE COMPARTMENT B NEXT TO THE DOOR. AFTER REMOVAL OF THE PLASTIC, THE FSE PERFORMED A NEW QCV THE SAME DAY AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE LEAK TESTS AND QCV PERFORMED ARE WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMERIEUX TO REPORT FAILED CALIBRATIONS IN SECTION B, SLOT 1 OF THE VIDAS INSTRUMENT W3205-A (SERIAL NUMBER (B)(4)). THE LAST SUCCESSFUL QCV (QUALITY CONTROL VERIFICATION) WAS PERFORMED 28-AUG-2015 ON THIS SECTION AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED A RETROSPECTIVE ANALYSIS AND RETESTED THE SAMPLES RUN IN THE PERIOD BETWEEN (B)(6) 2015 IN THE SECTION B, SLOT 1: LYME IGM, CMV IGM AND D-DIMERS (EXCEPT FOUR (4) D-DIMERS TEST). THE CUSTOMER IDENTIFIED A DISCREPANCY FOR ONE (1) PATIENT RESULT ON LYME IGM (B)(4): THE FIRST RESULT TESTED WAS NEGATIVE AT 0.04 ON (B)(6) 2015 AND POSITIVE AT 1.56 ON (B)(6) 2015. THE LOT NUMBER OF VIDAS LYME IGM (B)(4) USED WAS 1004058460 (EXPIRATION DATE 06-MAY-2016). THE PHYSICIAN WAS INFORMED OF THE FALSE NEGATIVE RESULT. AS PREVIOUS BLOOD TESTS PERFORMED ON THIS PATIENT IDENTIFIED HIM AS BEING POSITIVE FOR THE TEST LYME IGM, THERE WAS NO NEED TO RETEST THE PATIENT. THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE ON 07-SEP-2015: THE FSE DID NOT IDENTIFY ANY ANOMALY WITH THE INSTRUMENT EXCEPT A PIECE OF PLASTIC, LIKELY FROM A SPR, INSIDE THE COMPARTMENT B NEXT TO THE DOOR. HE PERFORMED A NEW QCV THE SAME DAY AND THE RESULTS WERE WITHIN SPECIFICATIONS. THE PRODUCT VIDAS LYME IGM (B)(4) IS NOT SOLD IN THE US, BUT A SIMILAR PRODUCT VIDAS LYME IGM II (B)(4) IS REGISTERED BY THE FDA. THERE IS NO INDICATION OR REPORT THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. THERE MAY BE A POTENTIAL FOR ADVERSE EVENT IF THE EVENT WERE TO REOCCUR. BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634962 VIDAS® LYME IGM ASSAY VIDAS® LYME IGM ASSAY LSR BIOMERIEUX SA 1004058460

    Patients

    Seq Age Sex Outcome Treatment
    1