BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 10951228 · Received December 5, 2020

    Report

    Report Number
    8020790-2020-00130
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Report Date
    February 1, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 NEGATIVE RESULT FOR A PATIENT SAMPLE, IN ASSOCIATION WITH THE VIDAS® SARS-COV-2 IGG (REF 423834, LOT 1008117730). THE CUSTOMER¿S SAMPLE COULD NOT BE SUBMITTED FOR INVESTIGATION AS THERE WAS NO MORE VOLUME AVAILABLE. ACCORDING TO THE ANALYSIS OF THE QUALITY DATA OF BATCH 1008117730, NO ANOMALIES DURING THE STAGES OF MANUFACTURE, QUALITY CONTROL AND PACKAGING WERE IDENTIFIED. ANALYSIS OF THE CONTROL CHARTS SHOWED LOT 1008117730 / 210528-0 WAS IN LINE WITH OTHER VIDAS® SARS COV IGG LOTS FOR TESTING OF FOUR (4) INTERNAL SAMPLES WITH A POSITIVE TARGET. THE SAMPLES COMPLIED WITH EXPECTATIONS. THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES (THREE WITH A POSITIVE TARGET AND ONE WITH A NEGATIVE TARGET) ON THE RETAIN KIT OF THE CUSTOMER¿S LOT 1008117730 / 210528-0. THE SAMPLE RESULTS COMPLIED WITH THE EXPECTED SPECIFICATION. THE LAB DID NOT OBSERVE ANY EVOLUTION OVER TIME OF VIDAS® SARS COV-2 IGG BATCH 1008117730 / 210528-0. THE CUSTOMER¿S RESULT WAS NOT REPRODUCED. WITHOUT ANY CONCERNED SAMPLE AVAILABLE, IT IS NOT POSSIBLE TO PURSUE FURTHER THE INVESTIGATION AND EXPLAIN THE RESULTS OBSERVED BY THIS CUSTOMER. ACCORDING TO THE INVESTIGATION, THERE IS NO RECONSIDERATION OF VIDAS® SARS COV-2 IGG REF. 423834 LOT 1008117730 / 210528-0.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A POTENTIAL FALSE NEGATIVE RESULT FOR A PATIENT SAMPLE, IN ASSOCIATION WITH THE VIDAS® SARS-COV-2 IGG (REF 423834, LOT 1008117730). THE CUSTOMER REPORTED THE FOLLOWING RESULTS REGARDING A (B)(6) FEMALE PATIENT: ON THE (B)(6) 2020: PCR RESULT = POSITIVE ON THE (B)(6) 2020: PCR RESULT = NEGATIVE VIDAS SARS COV IGG: RESULT = NEGATIVE INTERPRETATION NOVALISA NOVATEC (BIOMNIS) IGG: RESULT = EQUIVOCAL INTERPRETATION SARS COV IGG ABBOTT: RESULT = 2.29 (POSITIVE INTERPRETATION) REGARDING PATIENT HISTORY, IT WAS REPORTED BY THE CUSTOMER THAT THE FIRST SYMPTOMS APPEARED IN MID-(B)(6) 2020. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. NOTE: REFERENCE 423834 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423834-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423834.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415381 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008117730

    Patients

    Seq Age Sex Outcome Treatment
    1