BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGM

    MDR report key: 11449311 · Received March 9, 2021

    Report

    Report Number
    3008344661-2021-00056
    Event Type
    Malfunction
    Date Received
    March 9, 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
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    HIS 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 · 0

    COMPONENT CODE: G01003. THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE ARCHITECT SARS-COV-2 IGM RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELLING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. SPECIFICITY AND SENSITIVITY TESTING FOR REAGENT LOT 22167FN00 WAS COMPLETED USING AN IN-HOUSE RETAINED KIT OF THE COMPLAINT LOT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. TESTING WAS NOT COMPLETED FOR LOT 21679FN00 AS THE LOT EXPIRED, HOWEVER REVIEW OF THE CUSTOMER RELEASE TESTING (CRT) RESULTS FOR LOTS 22167FN00 AND 21679FN00 SHOWS THAT THE LOTS ARE PERFORMING SIMILARLY AND WELL WITHIN ACCEPTABLE LIMITS. DEVICE HISTORY RECORD REVIEW ON LOTS 22167FN00 AND 21679FN00 DID NOT SHOW ANY NON-CONFORMANCES, OR DEVIATIONS RELATING TO THE CUSTOMERS ISSUE. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. FIVE OF THE SAMPLES WERE NEGATIVE BUT SLIGHTLY ELEVATED/ELEVATED WITH THE MAGLUMI IGM ASSAY. TWO OF THE SAMPLES WERE ALSO POSITIVE ON A ROCHE TOTAL ASSAY. THE DIFFERENCE IN RESULTS BETWEEN THE ARCHITECT ASSAY AND THE MAGLUMI ASSAY IS POTENTIALLY DUE TO THE ARCHITECT ASSAY BEING MORE SENSITIVE. THE FIVE PATIENT SAMPLES WERE POSITIVE FOR IGG ON THE ARCHITECT AND MAGLUMI ASSAYS INDICATING THE SAMPLES ARE POSITIVE FOR ANTIBODY. THE MAGLUMI 2019-NCOV LGG/LGM ASSAY IS A JOINT DETECTION OF 2019-NCOV IGG AND IGM. PER THE MAGLUMI 2019-NCOV LGG/LGM CLIA ASSAYS INFORMATION SHEET, CLINICAL SENSITIVITY WAS DETERMINED IN CHINA BY TESTING CONFIRMED NOVEL CORONAVIRUS INFECTED SPECIMENS AND THE CLINICAL SPECIFICITY WAS DETERMINED IN CHINA BY TESTING NON-NOVEL CORONAVIRUS INFECTED SPECIMENS (INCLUDING NORMAL SAMPLES AND INTERFERENCE SAMPLES). PER STUDY 2 REFERENCED UNDER CLINICAL VERIFICATION, THE CLINICAL SPECIFICITY OF 2019-NCOV IGM (CLIA)+2019-NCOV IGG (CLIA) IS 96.0%. THE CLINICAL SENSITIVITY OF 2019-NCOV IGM (CLIA)+2019-NCOV IGG (CLIA) IS 95.6%. PER THE CLINICAL PERFORMANCE SECTION OF THE PACKAGE INSERT, A STUDY WAS PERFORMED TO ESTIMATE THE NEGATIVE PERCENT AGREEMENT (NPA), 2965 SERUM AND PLASMA SPECIMENS FROM SUBJECTS ASSUMED TO BE NEGATIVE FOR SARS-COV-2 WERE TESTED USING THE SARS-COV-2 IGM ASSAY. ALL OF THE SPECIMENS WERE COLLECTED PRIOR TO SEPTEMBER 2019 (PRE-COVID-19 OUTBREAK). THE NPA IS 99.56% (95% CI: 99.25, 99.74). AT THIS TIME, DURATION AND STRENGTH OF THE IGM ANTIBODY RESPONSE CONTINUE TO BE CHARACTERIZED; THE KINETICS OF THIS RESPONSE ARE UNKNOWN. 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 THE INVESTIGATION ARCHITECT SARS-COV-2 IGM REAGENT LOTS 22167FN00 AND 21679FN00 ARE PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGM REAGENT LOT(S) WAS IDENTIFIED.SECTION D3 SUSPECT MEDICAL DEVICE WAS UPDATED INCLUDING THE PHONE NUMBER, EMAIL, AND FAX NUMBER. SECTION G1 ALL MANUFACTURERS WAS UPDATED INCLUDING THE MFG SITE EMAIL AND MFG SITE FAX NUMBER.

    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. SID (B)(6) WAS PREVIOUSLY REPORTED UNDER MFR# 3008344661-2021-00040-00 FOR A DIFFERENT REAGENT LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT SARS-COV-2 IGM RESULTS FOR 1 PATIENT WHEN COMPARING THE ARCHITECT SARS-COV-2 IGM RESULTS TO THE MAGLUMI IGM RESULTS (CUTOFF IS < 1.00). THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGES PROVIDED FOR THE ASSAYS: ARCHITECT SARS-COV-2 IGG = CUTOFF IS < 1.40 INDEX. ARCHITECT SARS-COV-2 IGM = CUTOFF IS < 1.00 INDEX. MAGLUMI IGG = CUTOFF IS < 1.00. MAGLUMI IGM = CUTOFF IS < 1.00. ON (B)(6) 2021 SID (B)(6) FEMALE = ARCHITECT SARS-COV-2 IGG = 1.78 INDEX (POSITIVE); ARCHITECT SARS-COV-2 IGM = 2.86 INDEX (POSITIVE), REPEAT = 3.16 INDEX (POSITIVE); MAGLUMI IGG = 5.016 (POSITIVE), MAGLUMI IGM = 0.67 (NEGATIVE); ROCHE TOTAL = 9.18; (B)(6) 2020 PCR = POSITIVE; (B)(6) 2020 PCR = NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339467 SARS-COV-2 IGM SARS-COV-2 IGM QKO ABBOTT IRELAND 21679FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR ARC I2SR REFURB-SEKAT, 03M74-97, ISR52257| ARC I2SR REFURB-SEKAT, 03M74-97, ISR52257| ARC I2SR REFURB-SEKAT, 03M74-97, ISR52257