BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGM

    MDR report key: 11096344 · Received December 30, 2020

    Report

    Report Number
    8020790-2020-00148
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN ITALY REGARDING DISCREPANT RESULTS (POTENTIAL FALSE NEGATIVE RESULT) WITH THE PRODUCT VIDAS® SARS-COV-2 IGM (REF (B)(4), BATCH 1008312650, EXPIRY DATE 13-SEP-2021) COMPARED TO OTHER METHODS. THERE WAS NO QUANTITY LEFT OF THE CUSTOMER¿S SAMPLE TO BE SENT TO BIOMERIEUX FOR THE INVESTIGATION. THE ANALYSIS OF THE BATCH HISTORY RECORDS OF VIDAS® SARS COV-2 IGM BATCH 1008312650 / 210913-0 SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, AND PACKAGING PROCESSES. THE COMPLAINTS LABORATORY DID NOT REPRODUCE THE VIDAS® SARS COV-2 IGM NEGATIVE RESULT WITH INTERNAL SAMPLES TESTED ON THE RETAIN KIT OF THE CUSTOMER'S LOT. THE RESULTS OF THE INTERNAL SAMPLES WERE WITHIN SPECIFICATION RANGES AND WITHOUT ANY OBSERVATION OF INTERPRETATION CHANGE. THE CONTROL CHART ANALYSIS OF SIX (6) INTERNAL SAMPLES SHOWED THE CUSTOMER'S LOT, VIDAS® SARS COV-2 IGM REFERENCE (B)(4) BATCH 1008312650 / 210913-0, WAS IN THE TREND OF OTHER VIDAS® BATCHES. ALL OF THE SAMPLES WERE IN ACCORDANCE OF THEIR ACCEPTABLE RANGES. WITHOUT THE CUSTOMER¿S SAMPLE RETURN, BIOMERIEUX CANNOT FURTHER INVESTIGATE THIS ISSUE. ACCORDING TO THE INVESTIGATION, THERE IS NO RECONSIDERATION OF THE PERFORMANCE OF VIDAS® SARS COV-2 IGM REF. (B)(4) BATCH 1008312650 / 210913-0. IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS® SARS COV-2 IGM ASSAY AT SECTION LIMITATIONS OF THE METHOD: "THE INDIVIDUAL IMMUNE RESPONSE FOLLOWING SARS-COV-2 INFECTION VARIES CONSIDERABLY AND MIGHT GIVE DIFFERENT RESULTS WITH ASSAYS FROM DIFFERENT MANUFACTURERS. RESULTS OF ASSAYS FROM DIFFERENT MANUFACTURERS SHOULD NOT BE USED INTERCHANGEABLY." ABBOTT AND ROCHE METHODS DO NOT DETECT THE SAME TARGET (NUCLEOCAPSID) AS THE VIDAS® METHOD (RBD SUBUNIT OF SPIKE).SEE SECTION H10.

    Description of Event or Problem · 1

    ON THE 3RD OF DECEMBER 2020, A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY OBTAINED DISCREPANT RESULTS (POTENTIAL FALSE NEGATIVE RESULT) WITH THE PRODUCT VIDAS® SARS-COV-2 IGM (REF 423833, BATCH 1008312650, EXPIRY DATE 13-SEP-2021) COMPARED TO OTHER METHODS. THE CUSTOMER STATED THAT A PATIENT SAMPLE WAS REPEATEDLY POSITIVE (THREE TIMES) ON SWAB, EVEN AFTER HAVING SPENT 14 DAYS OF QUARANTINE, HE WAS NEGATIVE ONLY TO THE 4TH TEST (ON SWAB) THAT HAS BEEN PRACTICED. THE RESULTS WERE AS FOLLOWS: ABBOTT: IGM RESULT 1 = 1.63 ; IGM RESULT 2 = 1.10 : POSITIVE INTERPRETATION. ROCHE: IG RESULT = 2.18 : POSITIVE INTERPRETATION. VIDAS: IGM RESULT 1 = 0.39 ; IGM RESULT 2 = 0.39 ; IGM RESULT 3 = 0.45 : NEGATIVE INTERPRETATION. 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. 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
    1562143 VIDAS SARS-COV-2 IGM VIDAS® SARS-COV-2 IGM QKO BIOMERIEUX SA 1008312650

    Patients

    Seq Age Sex Outcome Treatment
    1