BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGM

    MDR report key: 10320346 · Received July 24, 2020

    Report

    Report Number
    8020790-2020-00058
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Report Date
    January 4, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN (B)(6) REGARDING A POTENTIAL FALSE POSITIVE RESULT WITH THE PRODUCT VIDAS¿ SARS-COV-2 IGM (REF 423833, BATCH 1008114880, EXPIRY DATE 28-MAY-2021) WITH A FEMALE PATIENT SAMPLE. THE QUALITY CONTROL RECORDS ANALYSIS ON VIDAS¿ SARS COV-2 IGM BATCH 1008114880 / 210528-0 SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, OR PACKAGING PROCESSES IN LINK WITH THE OBJECT OF THIS COMPLAINT. THERE WERE NEITHER CAPA NOR NON-CONFORMITIES RECORDED ON THIS VIDAS¿ ASSAY. AN ANALYSIS FOR FOUR (4) INTERNAL SAMPLES CONTROL CHARTS ON SIX (6) LOTS OF VIDAS¿ SARS COV-2 IGM REF. 423833, INCLUDING THE BATCH USED BY THE CUSTOMER (1008114880 / 210528-0) WAS PERFORMED. ALL THE SAMPLES WERE COMPLIANT TO THEIR SPECIFICATIONS AND VIDAS¿ SARS-COV-2 IGM 1008114880 / 210528-0 WAS IN THE TREND OF THE OTHER LOTS. TWO (2) SAMPLES WERE RETURNED BY THE CUSTOMER. THE COMPLAINTS LAB REPRODUCED THE VIDAS¿ SARS COV-2 IGM POSITIVE RESULT WHEN TESTING THE PATIENT'S SAMPLE, BUT THE SPECIFICITY TESTING PERFORMED ON NEGATIVE SAMPLES GAVE EXPECTED NEGATIVE RESULTS. IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE POSITIVE RESULT OBSERVED ON 1008114880 / 210528-0, BUT ACCORDING TO THE TESTING, IT IS DEDUCED THAT THE ISSUE IS NOT IN RELATION WITH RHEUMATOID FACTOR OR INTERNAL RAW MATERIAL SUCH AS RBD PROTEIN. THE PACKAGE INSERT OF VIDAS¿ SARS COV-2 IGM ASSAY REF. 423833 MENTIONS THE FOLLOWING: SECTION PERFORMANCE / SPECIFICITY: A TOTAL OF 308 SAMPLES COLLECTED FROM NEGATIVE INDIVIDUALS BEFORE (B)(6) 2019 WERE TESTED SINGLY USING THE VIDAS¿ SARS COV 2 IGM ASSAY ON THE VIDAS¿ INSTRUMENT. TWO FALSE POSITIVE SAMPLES WERE DETECTED. THE RESULTING OVERALL SPECIFICITY IN THE INTERNAL STUDY WAS 99.4% [97.7-99.9]. SECTION LIMITATIONS OF THE METHOD: INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT'S CLINICAL HISTORY AND THE RESULTS OF ANY OTHER TESTS PERFORMED. CONSEQUENTLY, ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS¿ SARS COV-2 IGM REF. 423833 LOT 1008114880 / 210528-0.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOM¿RIEUX OF OBTAINING A POTENTIAL FALSE POSITIVE RESULT WITH THE PRODUCT VIDAS¿ SARS-COV-2 IGM (REF 423833, BATCH 1008114880, EXPIRY DATE 28-MAY-2021) WITH A FEMALE PATIENT SAMPLE. FOR THE SAME PATIENT THE RESULTS WERE AS FOLLOWS: SARS-COV-2 IGG : NEGATIVE INTERPRETATION (RESULT = 0.02). VIDAS¿ SARS-COV-2 IGM: RESULT 1: 1.13, POSITIVE INTERPRETATION (VALUE NOT REPORTED). RESULT 2: 1.30, POSITIVE INTERPRETATION (VALUE NOT REPORTED). SARS COV 2  PCR TEST = NEGATIVE INTERPRETATION. THE CUSTOMER SUSPECTED FALSE POSITIVE RESULTS REGARDING SARS-COV-2 IGM. REGARDING THE CLINICAL CONTEXT, IT WAS REPORTED THAT THIS FEMALE PATIENT DIDNT PRESENT ANY SYMPTOMS AT THE TIME OF THE COMPLAINT. APPARENTLY THE PATIENT PRESENTED WITH COLD SYMPTOMS TWO MONTHS AGO. MOREOVER THE PATIENT HAS A MEDICAL HISTORY OF LYME DISEASE WHICH WAS DETECTED FEW YEARS AGO: ERYTHEMA MIGRANS WAS VISIBLE AND VIDAS LYME IGM WAS POSITIVE. SHE WAS TREATED AND THE SYMPTOMS DISAPPEARED BUT VIDAS LYME IGM IS STILL POSITIVE (VIDAS LYME IGG NEGATIVE). RF ; (B)(6): (B)(6). THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOM¿RIEUX HAS INITIATED AN INTERNAL INVESTIGATION. 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
    786360 VIDAS SARS-COV-2 IGM VIDAS® SARS-COV-2 IGM QKO BIOMERIEUX SA 1008114880

    Patients

    Seq Age Sex Outcome Treatment
    1