BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGM

    MDR report key: 11667349 · Received April 14, 2021

    Report

    Report Number
    8020790-2021-00087
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Report Date
    June 11, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN GERMANY REGARDING SUSPECTED FALSE POSITIVE RESULTS WHEN TESTING PATIENT¿S SAMPLES WITH VIDAS® SARS-COV-2 IGM (9COM) 60T (REF. 423833, LO: 1008090880, EXPIRY DATE: 09-MAY-2021). THE SAMPLES WERE COLLECTED FROM A PATIENT WHO SUFFERED FROM DISEASE LEADING TO HIGH LEVELS OF RHEUMATOID FACTOR. THE CUSTOMER¿S SAMPLE WAS REQUESTED AND RETURNED BY THE CUSTOMER FOR THE INVESTIGATION. ANALYSIS OF THE BATCH HISTORY RECORDS SHOWED NO ANOMALIES FOUND DURING THE MANUFACTURING, CONTROL AND PACKAGING OF VIDAS SARS COV-2 IGM LOT: 1008090880/210509-0. AN ANALYSIS OF INTERNAL SAMPLES CONTROL CHARTS WAS PERFORMED ON 5 INTERNAL SAMPLES WITH A POSITIVE TARGET ON THREE AND TWO WITH A NEGATIVE ONE. THERE WERE SEVEN LOTS OF VIDAS SARS COV-2 IGM ASSAY INCLUDING THE LOT MENTIONED BY CUSTOMER 1008090880/210509-0 WERE TESTED AND THE ANALYSIS SHOWED THAT THE SAMPLES COMPLY WITH THE EXPECTATIONS AND VIDAS SARS COV-2 IGM BATCH: 1008090880/210509-0 IS IN THE TREND COMPARED TO THE OTHER LOTS. THE COMPLAINT LABORATORY TESTED THE RETAINED PATIENT SAMPLE ID: (B)(6) ON 3 LOTS OF VIDAS SARS COV-2 IGM INCLUDING THE CUSTOMER BATCH: 1008090880/210509-0 AND FOUND A POSITIVE RESULT ON 2 OF THEM. THE COMPLAINT LABORATORY PERFORMED A SPECIFICITY STUDY WITH SAMPLES FROM BIOBANK ON 3 LOTS OF VIDAS SARS-COV-2 IGM (1008114880 / 210528-0; 1008090880 / 210509-0 AND 1008184830 / 210702-0. THE 30 SAMPLES WERE COLLECTED BEFORE THE PANDEMIC AND WHEN TESTED, OBTAINED NEGATIVE RESULTS AS EXPECTED .RESULTS RANGED BETWEEN 0.03 AND 0.22 SO FAR FROM THE POSITIVE THRESHOLD OF 1 TV. THE COMPLAINT LABORATORY TESTED THE RETURNED PATIENT SAMPLE FOR DETECTION OF RHEUMATOID FACTOR AND THE SAMPLE GAVE A NEGATIVE INTERPRETATION USING RHUMALATEX BIOSYNEX FUMOUZE BUT A POSITIVE ONE USING POLYARTITRE BIOSYNEX FUMOUZE. THIS COULD BE DUE TO ITS RHEUMATOID FACTOR TYPE. THE RETURNED PATIENT SAMPLE WAS SENT TO AN EXTERNAL LABORATORY TO BE TESTED USING A COMPETITOR METHOD NOVA-LISA IGM AND GAVE A NEGATIVE RESULT. ACCORDING TO THE SECTION CROSS REACTIVITY IN THE PACKAGE INSERT FOR THE VIDAS SARS COV-2 IGM REF. 423833, RHEUMATOID FACTOR WAS CONSIDERED AS POTENTIALLY INTERFERING SUBSTANCE AND SAMPLES WITH SUCH PROFILE WERE TESTED DURING THE DEVELOPMENT OF THE PRODUCT. 2 SAMPLES OUT OF 5 GAVE A POSITIVE RESULT DURING THE STUDY. ACCORDING TO THE INVESTIGATION, THE COMPLAINT LABORATORY REPRODUCED THE POSITIVE RESULT ON THE PATIENT SAMPLE USING 2 BATCHES OF VIDAS SARS COV-2 IGM REF. 423833 BUT DID NOT REPRODUCE THE POSITIVE RESULT WHEN TESTING NEGATIVE SAMPLES COLLECTED BEFORE THE PANDEMIC ON VIDAS SARS COV-2 IGM WITH THE LOT: 1008090880/210509-0. THE ROOT CAUSE COULD BE LINKED TO THE PRESENCE OF RHEUMATOID FACTOR IN THE SAMPLE, WHICH WAS IDENTIFIED AS A POTENTIALLY INTERFERING SUBSTANCE IN THE STUDIES CONDUCTED DURING THE DEVELOPMENT OF THE PRODUCT. IN ACCORDANCE TO THE INVESTIGATION, THE VIDAS SARS COV-2 IGM BATCH: 1008090880/210509-0 IS WITHIN THE EXPECTED PERFORMANCE.

    Description of Event or Problem · 0

    A CUSTOMER IN GERMANY NOTIFIED BIOMÉRIEUX OF OBTAINING SUSPECTED FALSE POSITIVE RESULTS WHEN TESTING PATIENT¿S SAMPLES WITH VIDAS® SARS-COV-2 IGM (9COM) 60T (REF. 423833, LOT 1008090880, EXPIRY DATE = 09-MAY-2021). THE PATIENT WAS A (B)(6) FEMALE. (B)(6). THERE IS NO INDICATION FROM THE CUSTOMER THAT THIS EVENT IMPACTED THE PATIENT STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 423833 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423833-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423833.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563880 VIDAS SARS-COV-2 IGM VIDAS® SARS-COV-2 IGM QKO BIOMERIEUX SA 1008090880

    Patients

    Seq Age Sex Outcome Treatment
    1