BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2-IGG REAGENT KIT

    MDR report key: 11240420 · Received January 27, 2021

    Report

    Report Number
    3008344661-2021-00027
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 13, 2021
    Report Date
    June 15, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    HEALTH EFFECT IMPACT CODE: F26 COMPONENT CODE: G01003 D8. WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. 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 POSSIBLE AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW ON LIST NUMBER 6R86 DID NOT IDENTIFY ANY NON-CONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. IN THIS CASE, NO DATA OR NO SPECIFIC PATIENT HISTORY WERE PROVIDED. 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. RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., SYMPTOMS, RESULTS OF OTHER TESTS, AND CLINICAL IMPRESSIONS. RESULTS FROM ANTIBODY TESTING SHOULD NOT BE USED AS THE SOLE BASIS TO DIAGNOSE OR EXCLUDE SARS-COV-2 INFECTION OR TO INFORM INFECTION STATUS. BASED ON CURRENT LITERATURE, IGG LEVELS MAY NOT APPEAR UNTIL 7 TO 10 DAYS AFTER INFECTION, LONG, Q-X, ET AL; HTTPS://WWW.NATURE.COM/ARTICLES/S41591-020-0897-1. 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, 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, HTTPS://DOI.ORG/10.1038/S41591-020-0965-6, 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 IGG 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. ANTIBODY RESPONSES TO SARS-COV-2 IN PATIENTS OF NOVEL CORONAVIRUS DISEASE 2019. MEDRXIV. REVIEW OF THE MANUSCRIPT, BRYAN ET AL. 2020, ¿PERFORMANCE CHARACTERISTICS OF THE ABBOTT ARCHITECT SARS-COV-2 IGG ASSAY AND SEROPREVALENCE IN BOISE, IDAHO¿ J. CLIN. MICROBIOL, DOI: 10.1128/JCM.00941-20, 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, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGG REAGENT ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS D8 AND/OR H6 WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED IN FIELD H10. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Additional Manufacturer Narrative · 1

    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 06R86-23 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). ALL PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    HOLD FOR GARY 2.10.THE CUSTOMER REPORTED FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG FOR A (B)(6) PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2020 THE PATIENT WAS DIAGNOSED WITH COVID BY PCR METHOD GENERATING A POSITIVE RESULT AND PATIENT ISOLATED FOR 2 WEEKS. ON (B)(6) 2021, THE PATIENT SAMPLE GENERATED A NEGATIVE RESULT FOR SARS-COV-2 IGG. THE CUSTOMER STATED THAT THE PATIENT RECOVERED AT A SHORT STAY FACILITY AND THAT HER SYMPTOMS ARE CURRENTLY RESOLVED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133285 SARS-COV-2-IGG REAGENT KIT REAGENT, CORONAVIRUS SEROLOGICAL QKO ABBOTT IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR ARC I2K PROC MOD, 03M74-01, ISR54622| ARC I2K PROC MOD, 03M74-01, ISR54622| ARC I2K PROC MOD, 03M74-01, ISR54622