BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGM

    MDR report key: 10758914 · Received October 29, 2020

    Report

    Report Number
    3008344661-2020-00095
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 3, 2020
    Report Date
    December 7, 2020
    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

    THE COMPLAINT INVESTIGATION FOR FALSELY POSITIVE ARCHITECT SARS-COV-2 IGM RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. CLINICAL SPECIFICITY AND SENSITIVITY WERE PERFORMED USING IN-HOUSE TESTING FOR REAGENT LOT 20611FN00 WAS COMPLETED USING A RETAINED SAMPLE OF THE COMPLAINT LOT STORED AT THE RECOMMENDED STORAGE CONDITION. 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. LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. THE CUSTOMER REPORTED FALSE POSITIVE RESULTS FOR 3 PATIENT SAMPLES WHEN TESTING WAS PERFORMED WITH ARCHITECT SARS-COV-2 IGM, LOT 20611FN00. A REVIEW OF CUSTOMER DATA ALIGNED WITH CUSTOMER¿S ISSUE AND NO ADDITIONAL ISSUES WERE IDENTIFIED. THE CUSTOMER FEELS THAT IN EACH CASE THE IGM RESPONSE IS TOO PROLONGED. 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, 326 SERUM AND PLASMA SPECIMENS WERE COLLECTED AT DIFFERENT TIMES FROM 103 SUBJECTS WHO TESTED POSITIVE FOR SARS-COV-2 BY A PCR METHOD AND WHO ALSO PRESENTED WITH COVID-19 SYMPTOMS. EACH SPECIMEN WAS TESTED USING THE SARS-COV 2 IGM ASSAY. THE PPA AND THE 95% CONFIDENCE INTERVAL (CI) WERE CALCULATED. 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. PER SUMMARY AND EXPLANATION SECTION OF THE PACKAGE INSERT, 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 LOT 20611FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGM REAGENT WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER (B)(4). PATIENT IDENTIFIER: SID (B)(6) ((B)(6)); SID (B)(6)(FEMALE); SID (B)(6) ((B)(6) FEMALE).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE ARCHITECT SARS-COV-2 IGM RESULTS FOR 3 PATIENTS. THE FOLLOWING DATA WAS PROVIDED (SARS-COV-2 IGM CUTOFF RANGE: < 1.00 S/C = NEGATIVE, >/= 1.00 S/C = POSITIVE): ON (B)(6) 2020 SID (B)(6) ((B)(6) MALE) = SARS-COV-2 IGG = 0.96 S/C (< 1.4 S/C = NEGATIVE); SARS-COV-2 IGM = 2.27 S/C (POSITIVE); PCR METHOD = POSITIVE ((B)(6) 2020); SYMPTOMS = SORE THROAT AND COLD ON (B)(6) 2020 SID (B)(6) (FEMALE WHO PRESENTED WITH MILD SYMPTOMS AND HUSBAND IS CONFIRMED POSITIVE BY PCR METHOD ON (B)(6) 2020) = SARS-COV-2 IGG = 0.18 S/C (NEGATIVE), REPEAT = 0.18 S/C (NEGATIVE); SARS-COV-2 IGM = 1.62 S/C (POSITIVE), REPEAT = 1.47 S/C (POSITIVE); SYMPTOMS = 2 DAYS OF FATIGUE, LACK OF TASTE AND SMELL FOR 10 DAYS, MILD NASAL CONGESTION ON (B)(6) 2020 SID (B)(6) ((B)(6) HYPERTENSIVE FEMALE CONFIRMED PCR POSITIVE ON (B)(6) 2020) = SARS-COV-2 IGG = 8.3 S/C (POSITIVE); SARS-COV-2-IGM = 11.26 S/C (POSITIVE); SYMPTOMS = FEVER FOR 4 DAYS, HEADACHE AND MUSCLE FATIGUE, LOST OF TASTE AND SMELL, AND BACK PAIN THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219691 SARS-COV-2 IGM SARS-COV-2 IGM QKO ABBOTT IRELAND 20611FN00

    Patients

    Seq Age Sex Outcome Treatment
    1