BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGG II QUANT REAGENT KIT

    MDR report key: 11657658 · Received April 13, 2021

    Report

    Report Number
    3008344661-2021-00081
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 26, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: DESCRIBE EVENT OR PROBLEM FIELD WAS UPDATED TO INCLUDE MORE PATIENT DATA. THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NEGATIVE ALINITY I SARS-COV-2 IGG II QUANT RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. SENSITIVITY AND SPECIFICITY TESTING WAS DONE USING AN IN-HOUSE RETAINED KIT OF LOT 25345FN00, STORED AT THE RECOMMENDED STORAGE CONDITIONS. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW ON LOT 25345FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. THE CUSTOMER REPORTED NEGATIVE RESULTS FOR A 72-YEAR FEMALE PATIENT WHO RECEIVED 2 DOSES OF THE SPUTNIK COVID-19 VACCINE WHEN TESTING WAS PERFORMED WITH ARCHITECT SARS-COV-2 IGG II QUANT, LOT NUMBER 25345FN00. THE PATIENT RECEIVED THE FIRST VACCINE DOSE ON THE 09FEB2021 AND THE SECOND DOSE ON THE 05MAR2021. A SAMPLE WAS DRAWN FROM THE PATIENT ON THE 26MAR2021 WITH NEGATIVE RESULTS OF 22.6 AND 21.3 AU/ML RETURNED. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND TESTED ON THE 04MAY2021 WHICH ALSO RETURNED A NEGATIVE RESULT OF 21.3 AU/ML. IN THIS CASE, NEGATIVE BUT ELEVATED RESULTS WERE OBTAINED FOR THE PATIENT FOR SAMPLES DRAWN ~21 DAYS AND ~60 DAYS AFTER RECEIVING THE SECOND DOSE OF THE VACCINE. THE SARS-COV-2 IGG II QUANT ASSAY IS DESIGNED TO DETECT IMMUNOGLOBULIN CLASS G (IGG) ANTIBODIES, INCLUDING NEUTRALIZING ANTIBODIES, TO THE RECEPTOR BINDING DOMAIN (RBD) OF THE S1 SUBUNIT OF THE SPIKE PROTEIN OF SARS-COV 2 IN SERUM AND PLASMA FROM INDIVIDUALS WHO ARE SUSPECTED TO HAVE HAD CORONAVIRUS DISEASE (COVID-19) OR IN SERUM AND PLASMA OF INDIVIDUALS THAT MAY HAVE BEEN INFECTED BY SARS-COV-2. SEVERAL COVID-19 VACCINES UTILIZE STRATEGIES THAT GENERATE ANTIBODY RESPONSE TO THE SPIKE PROTEIN, HOWEVER, THE SARS-COV-2 IGG II QUANT ASSAY DOES NOT HAVE AN ESTABLISHED PERFORMANCE CLAIM FOR INDIVIDUALS WHO HAVE RECEIVED A COVID-19 VACCINE. PER THE CLINICAL PERFORMANCE SECTION OF THE PACKAGE INSERT, THE ASSAY SENSITIVITY (PPA) AT = 15 DAYS POST-SYMPTOM ONSET IS 99.37% (95 % CI 96.50, 99.97). WHEN IMMUNOCOMPROMISED SPECIMENS WERE INCLUDED IN THE ASSESSMENT, THE OBSERVED PPA AT = 15 DAYS POST-SYMPTOM ONSET WAS 97.02% (95% CI: 93.22, 98.72). PER ¿SPUTNIK V COVID-19 VACCINE CANDIDATE APPEARS SAFE AND EFFECTIVE¿, THE LANCET, PUBLISHED ONLINE FEBRUARY 2, 2021, HTTPS://DOI.ORG/10.1016/S0140-6736(21)00191-4, THE SPUTNIK VACCINE USES A HETEROLOGOUS RECOMBINANT ADENOVIRUS APPROACH USING ADENOVIRUS 26 (AD26) AND ADENOVIRUS 5 (AD5) AS VECTORS FOR THE EXPRESSION OF THE SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 (SARS-COV-2) SPIKE PROTEIN. TWO DOSES OF THE SPUTNIK VACCINE ARE GIVEN 21 DAYS APART. INTERIM RESULTS FROM A PHASE 3 TRIAL OF THE SPUTNIK V COVID-19 VACCINE SHOWS VACCINE EFFICACY, BASED ON THE NUMBERS OF CONFIRMED COVID-19 CASES FROM 21 DAYS AFTER THE FIRST DOSE OF VACCINE (DAY OF DOSE 2), IS REPORTED AS 91·6% (95% CI 85·6¿95·2). BASED ON THE INVESTIGATION, ARCHITECT SARS-COV-2 IGG II QUANT REAGENT, LOT NUMBER 25345FN00, IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE REAGENT WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE NEGATIVE SARS-COV-2 IGG II QUANT RESULTS, ON AN ARCHITECT I1000SR ANALYZER, FOR A 72-YEAR-OLD FEMALE PATIENT WHO HAS BEEN FULLY VACCINATED WITH THE SPUTNIK COVID-19 VACCINE. THE FOLLOWING DATA WAS PROVIDED (<50.0 AU/ML IS NEGATIVE, >/=50.0 AU/ML IS POSITIVE): INITIAL RESULT, ON (B)(6) 2021, WAS 22.6, REPEAT WAS 21.3 AU/ML. THE FOLLOWING DATA WAS PROVIDED ON 05MAY2021: THE PATIENT WAS DRAWN AGAIN AND THE RESULT, ON 04MAY2021, WAS 21.3 AU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06S60-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06S60-20.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE NEGATIVE SARS-COV-2 IGG II QUANT RESULTS FOR A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAS BEEN FULLY VACCINATED WITH THE SPUTNIK COVID-19 VACCINE. THE FOLLOWING DATA WAS PROVIDED (<50.0 AU/ML IS NEGATIVE, >/=50.0 AU/ML IS POSITIVE): INITIAL RESULT, ON (B)(6) 2021, WAS 22.6, REPEAT WAS 21.3 AU/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556921 SARS-COV-2 IGG II QUANT REAGENT KIT SARS-COV-2 LGG QKO ABBOTT IRELAND 25345FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I1000SR MOD, 01L86-01, I1SR04155| ARC I1000SR MOD, 01L86-01, I1SR04155| ARC I1000SR MOD, 01L86-01, I1SR04155| ARC I1000SR MOD, 01L86-01, I1SR04155