BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGG

    MDR report key: 10398522 · Received August 12, 2020

    Report

    Report Number
    1415939-2020-00125
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 8, 2020
    Report Date
    October 16, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 6R86-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6R86-30. PATIENT IDENTIFIER SID'S: (B)(6).

    Additional Manufacturer Narrative · 1

    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, AND DEVICE HISTORY RECORDS AND SCIENTIFIC LITERATURE. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. RETURN TESTING WAS REQUESTED; HOWEVER, TESTING COULD NOT BE PERFORMED AS THE SAMPLES WERE RECEIVED THAWED. DEVICE HISTORY RECORD REVIEW ON LOTS 16263FN00 AND 16253FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS RELATED TO THE CUSTOMER OBSERVATION. IN-HOUSE SENSITIVITY TESTING FOR REAGENT LOTS 16263FN00 AND 16253FN00 WAS COMPLETED. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET INDICATING THAT THE LOTS ARE PERFORMING ACCEPTABLY. THE CUSTOMER OBTAINED NEGATIVE RESULTS FOR THIRTY PATIENT SAMPLES WHEN TESTING WAS PERFORMED USING ARCHITECT SARS-COV-2 IGG REAGENT LOTS 16263FN00 AND 16253FN0 IN COMPARISON TO POSITIVE RESULTS OBTAINED WITH VIRCELL IGG. 10 OF THE PATIENTS TESTED PCR POSITIVE WHERE 2 PATIENTS RETURNED AN INCONCLUSIVE PCR RESULT. NO PCR DATA WAS PROVIDED FOR THE REMAINING 18 PATIENTS. THE DATE OF SYMPTOM ONSET AND PCR TEST DATE IS UNKNOWN. DIRECT COMPARISON SHOULD NOT BE MADE BETWEEN THE ARCHITECT SARS-COV-2 IGG ASSAY AND VIRCELL IGG ASSAY. THE ARCHITECT SARS-COV-2 IGG IS DESIGNED TO DETECT IMMUNOGLOBULIN CLASS G (IGG) ANTIBODIES TO THE NUCLEOCAPSID PROTEIN OF SARS-COV-2 WHEREAS THE VIRCELL IGG ASSAY IS DESIGNED TO DETECT ANTIBODIES FOR BOTH SPIKE AND NUCLEOCAPSID PROTEINS. IN THIS CASE, THE DATE FOR SYMPTOM ONSET OR PCR POSITIVITY IS UNKNOWN. BASED ON CURRENT LITERATURE, LONG Q-X ET AL, 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, SEOW ET AL, ¿DOI.ORG/10.1101/2020.07.09.20148429¿, OU ET AL, ¿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. THE PRODUCT PACKAGE INSERT ADVISES THE ASSAY SENSITIVITY WITHIN THE 95% CONFIDENCE LEVEL IS 95.89%- 100.00%. PATIENTS HAVE DIFFERENT IMMUNE RESPONSES AND THE INSERT STATES THAT IMMUNOCOMPROMISED PATIENTS WHO HAVE COVID-19 MAY HAVE A DELAYED ANTIBODY RESPONSE AND PRODUCE LEVELS OF ANTIBODY WHICH MAY NOT BE DETECTED AS POSITIVE BY THE ASSAY. IN THIS CASE, NO SPECIFIC PATIENT HISTORY WAS PROVIDED FOR THE PATIENTS. NEGATIVE RESULTS DO NOT RULE OUT SARS-COV-2 INFECTION, PARTICULARLY IN THOSE WHO HAVE BEEN IN CONTACT WITH THE VIRUS. 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. PER PRODUCT LABELING 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. ADDITIONALLY, 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 ARCHITECT SARS-COV-2 IGG REAGENT LOTS 16263FN00 AND 16253FN00 ARE PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGG REAGENT WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULTS ON 30 PATIENTS THAT WERE POSITIVE BY THE VIRCELL ASSAY. 10 OF THE PATIENTS WERE ALSO POSITIVE BY PCR. RESULTS PROVIDED: DATE SID ABBOTT VIRCELL PCR: ON (B)(6) 2020 (B)(6) 0.180 (NEG) 1.811 (POS) POS. ON (B)(6) 2020 (B)(6) 0.210 (NEG) 2.418 (POS) POS. ON (B)(6) 2020 (B)(6) 0.220 (NEG) 3.949 (POS). ON (B)(6) 2020 (B)(6) 0.240 (NEG) 6.195 (POS) POS. ON (B)(6) 2020 (B)(6) 0.260 (NEG) 1.685 (POS) INCONCLUSIVE. ON (B)(6) 2020 (B)(6) 0.420 (NEG) 4.300 (POS). ON (B)(6) 2020 (B)(6) 0.440 (NEG) 2.779 (POS) POS. ON (B)(6) 2020 (B)(6) 0.450 (NEG) 9.269 (POS). ON (B)(6) 2020 (B)(6) 0.480 (NEG) 1.794 (POS) POS. ON (B)(6) 2020 (B)(6) 0.480 (NEG) 3.820 (POS). ON (B)(6) 2020 (B)(6) 0.520 (NEG) 2.714 (POS). ON (B)(6) 2020 (B)(6) 0.560 (NEG) 2.915 (POS) INCONCLUSIVE. ON (B)(6) 2020 (B)(6) 0.570 (NEG) 10.891 (POS). ON (B)(6) 2020 (B)(6) 0.660 (NEG) 3.291 (POS). ON (B)(6) 2020 (B)(6) 0.790 (NEG) 12.772 (POS). ON (B)(6) 2020 (B)(6) 0.950 (NEG) 5.285 (POS) POS. ON (B)(6) 2020 (B)(6) 1.010 (NEG) 11.472 (POS) POS. ON (B)(6) 2020 (B)(6) 1.020 (NEG) 3.379 (POS) POS. ON (B)(6) 2020 (B)(6) 1.110 (NEG) 3.231 (POS). ON (B)(6) 2020 (B)(6) 1.120 (NEG) 5.326 (POS). ON (B)(6) 2020 (B)(6) 1.140 (NEG) 4.946 (POS). ON (B)(6) 2020 (B)(6) 1.160 (NEG) 4.749 (POS). ON (B)(6) 2020 (B)(6) 1.180 (NEG) 7.094 (POS) POS. ON (B)(6) 2020 (B)(6) 1.190 (NEG) 5.903 (POS). ON (B)(6) 2020 (B)(6) 1.250 (NEG) 3.820 (POS). ON (B)(6) 2020 (B)(6) 1.280 (NEG) 7.243 (POS). ON (B)(6) 2020 (B)(6) 1.320 (NEG) 6.471 (POS). ON (B)(6) 2020 (B)(6) 1.350 (NEG) 5.945 (POS), ON (B)(6) 2020 (B)(6) 1.370 (NEG) 12.304 (POS), ON (B)(6) 2020 (B)(6) 1.370 (NEG) 7.232 (POS) POS, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859993 SARS-COV-2 IGG COV-2 IGG QKO ABBOTT LABORATORIES 16263FN00

    Patients

    Seq Age Sex Outcome Treatment
    1