BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGM

    MDR report key: 11681581 · Received April 16, 2021

    Report

    Report Number
    3008344661-2021-00087
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 29, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (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. (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 · 0

    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 AND SENSITIVITY TESTING WERE DONE USING AN IN-HOUSE RETAINED KIT OF LOT 23525FN00, 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 23525FN00 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 TWO PATIENT SAMPLES WHEN TESTING WAS PERFORMED WITH ARCHITECT SARS-COV-2 IGM, LOT 23525FN00. PATIENT #1/SAMPLE ID 174569 RESULT WAS 1.88 INDEX (S/C), REPEATED, USING A MINI VIDAS ASSAY, WAS 0.23 (NO UNITS OF MEASURE WERE PROVIDED), WHICH IS NEGATIVE, TESTED WITH AN IFLASH 1800 ASSAY WAS ALSO NEGATIVE. THE PATIENT¿S PCR TESTING WAS NEGATIVE. PATIENT #2/SAMPLE ID 174568 RESULT WAS 1.12 INDEX (S/C), REPEATED, USING A MINI VIDAS ASSAY, WAS 0.77 (NO UNITS OF MEASURE WERE PROVIDED), WHICH IS NEGATIVE, TESTED WITH AN IFLASH 1800 ASSAY WAS ALSO NEGATIVE. THE PATIENT¿S PCR TESTING WAS NEGATIVE. NO PATIENT HISTORY WAS PROVIDED; IT IS UNKNOWN IF THESE PATIENTS WERE PREVIOUSLY DIAGNOSED WITH COVID-19 OR HAD BEEN VACCINATED. IN THIS CASE, NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. A DIRECT COMPARISON SHOULD NOT BE MADE BETWEEN THE ARCHITECT SARS-COV-2 IGM ASSAY AND THE BIOMÉRIEUX VIDAS® SARS-COV-2 IGM ASSAY AS THEY UTILIZE DIFFERENT TEST PRINCIPLES. THE ARCHITECT SARS-COV-2 IGM ASSAY UTILIZES CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) TECHNOLOGY AND IS DESIGNED TO DETECT IMMUNOGLOBULIN CLASS M (IGM) ANTIBODIES TO THE SPIKE PROTEIN OF SARS-COV-2 WHEREAS THE VIDAS® SARS-COV-2 IGM IS AN ENZYME IMMUNOASSAY METHOD WITH A FINAL FLUORESCENCE DETECTION (ELFA). THE PANTEC IFLASH METHOD ALSO UTILIZES CMIA TECHNOLOGY BUT INFORMATION ON THE SPECIFICITY OF THE IGM DETECTED COULD NOT BE SOURCED. IT IS POSSIBLE THAT THE ARCHITECT SARS-COV-2 IGM ASSAY HAS A HIGHER SENSITIVITY. 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 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). A STUDY WAS ALSO PERFORMED TO ESTIMATE THE POSITIVE PERCENT AGREEMENT (PPA), BETWEEN THE SARS-COV-2 IGM ASSAY AND THE POLYMERASE CHAIN REACTION (PCR) COMPARATOR, THE PPA AT = 31 DAYS POST-POSITIVE PCR RESULT IS 100.00% (95% CI: 51.01, 100.00). TWENTY-EIGHT (28) SPECIMENS FROM 8 IMMUNOCOMPROMISED PATIENT WERE EXCLUDED FROM THE STUDY. WHEN THE RESULTS FROM THESE SPECIMENS WERE INCLUDED, THE PPA AT = 31 DAYS POST-POSITIVE PCR RESULT WAS 80.00% (95% CI: 37.55, 98.97). IT SHOULD BE NOTED THAT THE DURATION OF THE IGM ANTIBODY RESPONSE HAS NOT BEEN FULLY CHARACTERIZED. THESE STUDY RESULTS ARE REPRESENTATIVE PERFORMANCE DATA. RESULTS OBTAINED IN INDIVIDUAL LABORATORIES MAY VARY. 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 23525FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED. THIS FOLLOW UP IS BEING SUBMITTED TO INCLUDE D8 AND H6 INFORMATION PREVIOUSLY SUBMITTED USING THE H10 SECTION IN THEIR RESPECTIVE FIELDS.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE POSITIVE SARS-COV-2 IGM RESULT FOR TWO PATIENTS ON AN ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED (<1.00 INDEX (S/C) IS NEGATIVE, >/=1.00 INDEX (S/C) IS POSITIVE): PATIENT #1/SAMPLE ID (B)(6) RESULT WAS 1.88 INDEX (S/C), REPEATED, USING A MINI VIDAS ASSAY, WAS 0.23 (NO UNITS OF MEASURE WERE PROVIDED), WHICH IS NEGATIVE, TESTED WITH AN IFLASH 1800 ASSAY WAS ALSO NEGATIVE. THE PATIENT¿S PCR TESTING WAS NEGATIVE. PATIENT #2/SAMPLE ID (B)(6) RESULT WAS 1.12 INDEX (S/C), REPEATED, USING A MINI VIDAS ASSAY, WAS 0.77 (NO UNITS OF MEASURE WERE PROVIDED), WHICH IS NEGATIVE, TESTED WITH AN IFLASH 1800 ASSAY WAS ALSO NEGATIVE. THE PATIENT¿S PCR TESTING WAS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578765 SARS-COV-2 IGM SARS-COV-2 IGM QKO ABBOTT IRELAND 23525FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I1000SR MOD, 01L86-01, (B)(4)| ARC I1000SR MOD, 01L86-01, (B)(4)