BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGG REAGENT KIT

    MDR report key: 10518724 · Received September 10, 2020

    Report

    Report Number
    1415939-2020-00154
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    June 5, 2020
    Report Date
    November 15, 2020
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6). ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06R86-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06R86-20.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATION FOR FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, SCIENTIFIC LITERATURE AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETE AS PATIENT SAMPLES WERE NOT AVAILABLE. SENSITIVITY AND SPECIFICITY TESTING WERE DONE USING AN IN-HOUSE RETAINED KIT OF LOT 16253FN00, 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 16253FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. THE CUSTOMER OBTAINED NEGATIVE RESULTS FOR SEVERAL PATIENT SAMPLES WHEN TESTING WAS PERFORMED USING ARCHITECT SARS-COV-2 IGG REAGENT LOT 16253FN00 IN COMPARISON TO POSITIVE RESULTS OBTAINED WITH THE COVIDAR IGG ASSAY. IN THIS CASE, NO SPECIFIC PATIENT HISTORY WAS PROVIDED FOR THE PATIENTS. THE ELISA METHOD USED DETECTS THE SPIKE PROTEIN OF THE VIRUS, WHEREAS THE ARCHITECT SARS-COV-2 IGG ASSAY DETECTS THE NUCLEOCAPSID PROTEIN. PER THE PRODUCT LABELING 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. 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. 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. 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 16253FN00 IS 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 OBSERVED FALSE NEGATIVE SARS-COV-2 IGG RESULTS FOR SEVERAL PATIENTS ON AN ARCHITECT I1000SR. THE FOLLOWING DATA WAS PROVIDED (<1.4 INDEX (S/C) IS NEGATIVE, >/=1.4 INDEX (S/C) IS POSITIVE): SAMPLE ID (B)(6), ON (B)(6) 2020, WAS 1.21 INDEX (S/C); SAMPLE ID (B)(6), ON (B)(6) 2020, WAS 0.52 INDEX (S/C); SAMPLE ID (B)(6), ON (B)(6) 2020, WAS 0.06 INDEX (S/C); SAMPLE ID (B)(6), ON (B)(6) 2020, WAS 0.02 INDEX (S/C); SAMPLE ID (B)(6), ON (B)(6) 2020, WAS 0.39 INDEX (S/C); SAMPLE ID (B)(6), ON (B)(6) 2020, WAS 0.58 INDEX (S/C). ALL PATIENTS WERE POSITIVE WHEN TESTED WITH THE COVIDAR IGG ASSAY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980176 SARS-COV-2 IGG REAGENT KIT SARS-COV-2 IGG QKO ABBOTT LABORATORIES 16253FN00

    Patients

    Seq Age Sex Outcome Treatment
    1