BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2-IGG REAGENT KIT

    MDR report key: 10740029 · Received October 27, 2020

    Report

    Report Number
    3008344661-2020-00089
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    October 3, 2020
    Report Date
    December 1, 2020
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, SCIENTIFIC LITERATURE AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. DEVICE HISTORY RECORD REVIEW ON LOT 19483FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. IN-HOUSE TESTING FOR REAGENT LOT 19483FN00 WAS COMPLETED USING A RETAINED SAMPLE OF THE COMPLAINT LOT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. THE CUSTOMER OBSERVED A FALSE NEGATIVE RESULT FOR ONE PATIENT SAMPLE WHEN TESTING WAS PERFORMED USING ARCHITECT SARS-COV-2 IGG REAGENT LOT 19483FN00. POSITIVE RESULTS WERE OBTAINED WITH TWO RAPID CARD TESTS (MEDSOURCE OZONE BIOMEDICALS IGG/IGM AND NUVISION RAPID IGG/IGM). THE PATIENT WAS ADMITTED WITH COVID-19 SYMPTOMS IN (B)(6) 2020 AND THE IGG TEST WAS PERFORMED 45 DAYS AFTER SYMPTOM ONSET. A DIRECT COMPARISON SHOULD NOT BE MADE BETWEEN THE ARCHITECT SARS-COV-2 IGG ASSAY AND THE TWO RAPID CARD TESTS (MEDSOURCE OZONE BIOMEDICALS IGG/IGM AND NUVISION RAPID IGG/IGM) AS THEY ARE DIFFERENT TEST METHODOLOGIES. IN THIS CASE, NO SPECIFIC PATIENT HISTORY WAS PROVIDED FOR THE PATIENTS. PER THE PRODUCT LABELING THE ASSAY SENSITIVITY WITHIN THE 95% CONFIDENCE LEVEL IS 95.89%- 100.00%. NEGATIVE RESULTS DO NOT RULE OUT SARS-COV-2 INFECTION, PARTICULARLY IN THOSE WHO HAVE BEEN IN CONTACT WITH THE VIRUS. FOLLOW-UP TESTING WITH A MOLECULAR DIAGNOSTIC SHOULD BE CONSIDERED TO RULE OUT INFECTION IN THESE INDIVIDUALS. BASED ON CURRENT LITERATURE, LONG, Q-X ET AL, ¿HTTPS://WWW.NATURE.COM/ARTICLES/S41591-020-0897-1¿, IGG LEVELS MAY NOT APPEAR UNTIL 7 TO 10 DAYS AFTER INFECTION. IN ADDITION, EMERGING LITERATURE ON SARS COV-2 SEROLOGY INDICATES THAT ANTIBODY RESPONSES TO THE VIRUS DECLINE OVER TIME. IN SOME CASES, THIS TRANSIENT RESPONSE RESULTS IN THE DECLINE OF BOTH IGG AND NEUTRALIZING ANTIBODY TITERS. IT REMAINS UNKNOWN FOR HOW LONG ANTIBODIES PERSIST FOLLOWING INFECTION AND IF THE PRESENCE OF ANTIBODIES IS INDICATIVE OF PROTECTIVE IMMUNITY, SEOW ET AL, ¿HTTPS://DOI.ORG/10.1101/2020.07.09.20148429¿, AND OU ET AL, ¿HTTPS://DOI.ORG/10.1101/2020.05.22.20102525¿. IT REMAINS UNKNOWN FOR HOW LONG ANTIBODIES PERSIST FOLLOWING INFECTION AND IF THE PRESENCE OF ANTIBODIES IS INDICATIVE OF PROTECTIVE IMMUNITY. THE STUDY, QUAN-XIN LONG ET AL, ¿CLINICAL AND IMMUNOLOGICAL ASSESSMENT OF ASYMPTOMATIC SARS-COV-2 INFECTIONS¿, NATURE MEDICINE, OBSERVED THAT IGG LEVELS AND NEUTRALIZING ANTIBODIES IN A HIGH PROPORTION OF INDIVIDUALS WHO RECOVERED FROM SARS-COV-2 INFECTION START TO DECREASE WITHIN 2¿3 MONTHS AFTER INFECTION. TO ASSESS THE CLINICAL PERFORMANCE OF THE ASSAY, A STUDY WAS PERFORMED USING 122 SERUM AND PLASMA SPECIMENS COLLECTED AT DIFFERENT TIMES FROM 31 SUBJECTS WHO TESTED POSITIVE FOR SARS-COV-2 BY A POLYMERASE CHAIN REACTION (PCR) METHOD AND WHO ALSO PRESENTED WITH COVID-19 SYMPTOMS. THE POSITIVE PERCENT AGREEMENT (PPA) AT >/=14 DAYS POST-SYMPTOM ONSET IS 100.00% (95% CI: 95.89, 100.00). FIVE SPECIMENS FROM 1 IMMUNOCOMPROMISED PATIENT WERE EXCLUDED FROM THE STUDY. WHEN THE RESULTS FROM THESE SPECIMENS WERE INCLUDED, THE PPA AT >/=14 DAYS POST-SYMPTOM ONSET WAS 96.77% (95% CI: 90.86, 99.33). THIS STUDY WAS BASED ON A HOSPITALIZED/SYMPTOMATIC POPULATION. DIFFERENCES IN ANTIBODY RESPONSES BETWEEN POPULATIONS, BASED ON MORE SEVERE VERSUS LESS SEVERE ILLNESS, ARE CONSISTENT WITH PUBLISHED REPORTS, ZHAO J ET AL. 2020. ADDITIONALLY, REVIEW OF THE MANUSCRIPT ¿PERFORMANCE CHARACTERISTICS OF THE ABBOTT ARCHITECT SARS-COV-2 IGG ASSAY AND SEROPREVALENCE IN BOISE, IDAHO¿, BRYAN ET AL. 2020, SHOWED SENSITIVITY DATA CONSISTENT WITH PRODUCT LABELING. 125 PATIENTS WHO TESTED RT-PCR POSITIVE FOR SARS-COV-2 FOR WHICH 689 EXCESS SERUM SPECIMENS WERE AVAILABLE WAS TESTED AND IT WAS FOUND THAT SENSITIVITY REACHED 100% AT DAY 17 AFTER SYMPTOM ONSET AND DAY 13 AFTER PCR POSITIVITY. BASED ON THE INVESTIGATION ARCHITECT SARS-COV-2 IGG REAGENT LOT 19483FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGG REAGENT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    POSTAL ZIP CODE: (B)(6). NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6R86-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 6R86-20/30.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSE NEGATIVE SARS-COV2 IGG RESULT GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR ONE PATIENT ON (B)(6) 2020. THE SAMPLE WAS NEGATIVE FOR SARS-COV2 IGG AND POSITIVE WITH TWO RAPID CARD TESTS (MEDSOURCE OZONE BIOMEDICALS IGG/IGM AND NUVISION RAPID IGG/IGM). NO SPECIFIC TEST VALUES WERE PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204009 SARS-COV-2-IGG REAGENT KIT REAGENT, CORONAVIRUS SEROLOGICAL QKO ABBOTT IRELAND 19483FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I1000SR INTGR, 01L86-40, I1SR56786| ARC I1000SR INTGR, 01L86-40, I1SR56786| ARC I1000SR INTGR, 01L86-40, I1SR56786