BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGM

    MDR report key: 11298454 · Received February 8, 2021

    Report

    Report Number
    3008344661-2021-00038
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    September 28, 2020
    Report Date
    May 27, 2021
    Manufacturer
    ABBOTT IRELAND
    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 = SAMPLE ID (B)(6), SAMPLE ID (B)(6), AND SAMPLE ID (B)(6). REPORTER PHONE 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 06R87-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06R87-20.

    Additional Manufacturer Narrative · 1

    (B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. ADDITIONAL PATIENT DATA WAS PROVIDED BY THE CUSTOMER ON (B)(6) 2021 AND WAS ADDED TO DESCRIBE EVENT OR PROBLEM. THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE ARCHITECT SARS-COV-2 IGM 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. SPECIFICITY TESTING WAS DONE USING AN IN-HOUSE RETAINED KIT OF LOT 20611FN00, 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 20611FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. THE CUSTOMER REPORTED POSITIVE RESULTS FOR THREE PATIENT SAMPLES WHEN TESTING WAS PERFORMED WITH ARCHITECT SARS-COV-2 IGM, LOT 20611FN00. PATIENT 1 WAS REPORTED TO HAVE COVID-19 IN (B)(6) 2020 WITH LOSS OF SMELL BUT NO VIROLOGY CONFIRMATION. THE DOCTOR QUERIED THE POSITIVE IGM RESULT SEVERAL MONTHS AFTER INFECTION. SID (B)(6) WAS TESTED ON THE (B)(6) 2020 WITH A POSITIVE IGM (2.16 INDEX) AND NEGATIVE IGG (1.29 INDEX) RESULTS. THE PATIENT WAS RETESTED ON THE (B)(6) 2021 WITH A BORDERLINE POSITIVE IGM RESULT OF 1.04 INDEX AND A NEGATIVE IGG RESULT OF 0.39 INDEX. THE PATIENT WAS REPORTED TO BE RHEUMATOID FACTOR (RF) POSITIVE DURING A LABORATORY CONTROL. PATIENT 2, SID (B)(6), WAS TESTED ON THE (B)(6) 2021 WITH A POSITIVE IGM RESULT (6.63 INDEX) AND A NEGATIVE IGG RESULT (0.02 INDEX). SID (B)(6) PREVIOUSLY DRAWN ON THE (B)(6) 2020 HAD A NEGATIVE IGG RESULT OF 0.03 INDEX. THE SAMPLE WAS STORED FROZEN AND WAS RE-TESTED FOR IGM AS 7.70 INDEX. PATIENT 3, SID (B)(6), TESTED ON THE (B)(6) 2020 RETURNING A POSITIVE IGM RESULT (3.35 INDEX) AND A NEGATIVE IGG RESULT (0.07 INDEX). THE SAMPLE WAS PROCESSED USING AN IN HOUSE TECHNIQUE TO PRECIPITATE RF AND THE RESULTS FOR BOTH IGG AND IGM CAME OUT NEGATIVE. THIS PATIENT RECEIVED THE SPUTNIK VACCINE ON THE (B)(6) 2021 AND (B)(6) 2021 AND WAS RETESTED ON THE (B)(6) 2021 AND THE (B)(6) 2021 WITH POSITIVE IGM RESULTS AND NEGATIVE IGG RESULTS. IN THIS CASE, PATIENT 1 WAS REPORTED TO HAVE A HISTORY OF COVID INFECTION AND IGG, ALTHOUGH NEGATIVE, WAS ELEVATED. NO SPECIFIC PATIENT HISTORY WAS PROVIDED FOR PATIENTS 2 AND 3. PATIENT 3 RETURNED A POSITIVE IGM RESULT PRIOR TO RECEIVING THE SPUTNIK VACCINE; HOWEVER, ADDITIONAL TESTING PERFORMED BY THE CUSTOMER TO PRECIPITATE RF RETURNED A NEGATIVE IGM RESULT USING AN IN HOUSE TEST WHICH COULD INDICATE POTENTIAL INTERFERENCE. POSITIVE IGM RESULTS POST VACCINATION ARE AS EXPECTED. 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 (B)(6) 2019 (PRE-COVID-19 OUTBREAK). THE NPA IS 99.56% (95% CI: 99.25, 99.74). PER IGM PRODUCT LABELING, THE HOST IMMUNE SYSTEM REACTS TO THE INFECTION BY SARS-COV-2 BY PRODUCING SPECIFIC ANTIBODIES. THESE ANTIBODIES HAVE BEEN REPORTED TO APPEAR IN SERUM OR PLASMA OF INFECTED INDIVIDUALS AFTER THE DETECTION OF VIRAL RIBONUCLEIC ACID (RNA) IN SWABS AND A FEW DAYS TO 2 WEEKS AFTER THE ONSET OF SYMPTOMS. SPECIFIC IGM ANTIBODIES TO SARS-COV-2 MAY BE DETECTABLE IN COVID-19 PATIENTS DURING THE SYMPTOMATIC PHASE OF THE DISEASE AFTER RNA IS NO LONGER DETECTABLE. AT THIS TIME, DURATION AND STRENGTH OF THE IGM ANTIBODY RESPONSE CONTINUE TO BE CHARACTERIZED; THE KINETICS OF THIS RESPONSE ARE UNKNOWN. PER PRODUCT LABELING, RHEUMATOID FACTOR (RF) IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. 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 LOT 20611FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGM REAGENT WAS IDENTIFIED.UPON INVESTIGATION, IT WAS DISCOVERED THAT THE RESULT OF 0.03 INDEX (S/C) FOR SAMPLE ID (B)(6) WAS FROM AN IGG ASSAY, NOT AN IGM ASSAY, AS WAS STATED IN THE PREVIOUS

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP IS SUBMITTED TO POPULATE FIELDS WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE POSITIVE SARS-COV-2 IGM RESULTS FOR THREE PATIENTS ON AN ARCHITECT I1000SR ANALYZER, WHEN COMPARED TO SARS-COV-2 IGG RESULTS. THE FOLLOWING DATA WAS PROVIDED (<1.0 INDEX (S/C) IS NEGATIVE, >/=1.00 INDEX (S/C) IS POSITIVE): SAMPLE ID (B)(6), A PATIENT WHO HAD REPORTED HAVING COVID-19 IN (B)(6) 2020, WITH LOSS OF SMELL BUT NO VIROLOGY CONFORMATION, IGM RESULT, ON (B)(6) 2020, WAS 2.16 INDEX (S/C); IGG RESULT WAS 1.29 INDEX (S/C), WHICH IS NEGATIVE. SAMPLE ID (B)(6), IGM RESULT, ON (B)(6) 2021, WAS 6.63 INDEX (S/C), A PREVIOUSLY IGM NEGATIVE SAMPLE (0.03 INDEX (S/C)) FOR THIS PATIENT, SAMPLE ID (B)(6) FROM (B)(6) 2020, THAT WAS FROZEN, WAS RETESTED WITH THIS SAMPLE AND THE RESULT WAS 7.70 INDEX (S/C); IGG RESULT WAS 0.02 INDEX (S/C), WHICH IS NEGATIVE. SAMPLE ID (B)(6), IGM RESULT, ON (B)(6) 2020, WAS 3.35 INDEX (S/C); IGG RESULT WAS 0.07 INDEX (S/C), WHICH IS NEGATIVE. THIS SAMPLE WAS PROCESSED USING ANOTHER AND THE RESULTS FOR BOTH IGG AND IGM WERE NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE POSITIVE SARS-COV-2 IGM RESULTS FOR THREE PATIENTS ON AN ARCHITECT I1000SR ANALYZER, WHEN COMPARED TO SARS-COV-2 IGG RESULTS. THE FOLLOWING DATA WAS PROVIDED (<1.0 INDEX (S/C) IS NEGATIVE, >/=1.00 INDEX (S/C) IS POSITIVE): SAMPLE ID (B)(6), A PATIENT WHO HAD REPORTED HAVING COVID-19 IN (B)(6) 2020 WITH LOSS OF SMELL BUT NO VIROLOGY CONFORMATION, IGM RESULT, ON (B)(6) 2020, WAS 2.16 INDEX (S/C); IGG RESULT WAS 1.29 INDEX (S/C), WHICH IS NEGATIVE. SAMPLE ID (B)(6) IGM RESULT, ON (B)(6) 2021, WAS 6.63 INDEX (S/C), A PREVIOUSLY IGG NEGATIVE SAMPLE (0.03 INDEX (S/C)) FOR THIS PATIENT, SAMPLE ID (B)(6) FROM (B)(6) 2020 THAT WAS FROZEN, WAS RETESTED WITH THIS SAMPLE AND THE RESULT WAS 7.70 INDEX (S/C); IGG RESULT WAS 0.02 INDEX (S/C), WHICH IS NEGATIVE. SAMPLE ID (B)(6) IGM RESULT, ON (B)(6) 2020, WAS 3.35 INDEX (S/C); IGG RESULT WAS 0.07 INDEX (S/C), WHICH IS NEGATIVE. THIS SAMPLE WAS PROCESSED USING ANOTHER AND THE RESULTS FOR BOTH IGG AND IGM WERE NEGATIVE. ADDITIONAL PATIENT DATA WAS PROVIDED BY THE CUSTOMER ON (B)(6) 2021: FOR SAMPLE ID (B)(6), THIS PATIENT WAS RETESTED ON (B)(6) 2021, WITH SAMPLE ID (B)(6), AND THE RESULTS WAS 1.04 INDEX (S/C); THE IGG RESULT WAS 0.39 INDEX (S/C), WHICH IS NEGATIVE. FOR SAMPLE ID (B)(6), THIS PATIENT WAS RETESTED ON (B)(6) 2021, WITH SAMPLE ID (B)(6), AND THE RESULT WAS 6.65 INDEX (S/C); IGG RESULT WAS 0.07 INDEX (S/C), WHICH IS NEGATIVE. THE PATIENT WAS RETESTED ON (B)(6) 2021, WITH SAMPLE ID (B)(6), AND THE RESULT WAS 4.45 INDEX (S/C); IGG RESULT WAS 0.07 INDEX (S/C), WHICH IS NEGATIVE. THIS PATIENT WAS VACCINATED WITH THE SPUTNIK VACCINE ON (B)(6) 2021 AND (B)(6) 2021. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189893 SARS-COV-2 IGM SARS-COV-2 IGM QKO ABBOTT IRELAND 20611FN00

    Patients

    Seq Age Sex Outcome Treatment
    1