BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2 IGM

    MDR report key: 10738527 · Received October 26, 2020

    Report

    Report Number
    3008344661-2020-00088
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 22, 2020
    Report Date
    February 14, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER OBSERVED POSITIVE RESULTS FOR TWO PATIENT SAMPLES WHEN TESTING WAS PERFORMED WITH ARCHITECT SARS-COV-2 IGM, LOT 20611FN00 IN COMPARISON TO NEGATIVE RESULTS OBTAINED WITH IMMUNOANALYSIS AT A REFERENCE LABORATORY. ONE SAMPLE TESTED NEGATIVE AND ONE SAMPLE TESTED POSITIVE ON MINI VIDAS. A DIRECT COMPARISON SHOULD NOT BE MADE BETWEEN THE ARCHITECT SARS-COV-2 IGM ASSAY AND THE BIOMERIEUX VIDAS® SARS-COV-2 IGM ASSAY AS BOTH ASSAYS UTILIZES DIFFERENT TEST PRINCIPLES. THE ARCHITECT SARS-COV-2 IGM ASSAY UTILIZES CHEMILUMINESCENT MICROPARTICLE IMMUNOASSAY (CMIA) TECHNOLOGY WHEREAS THE VIDAS® SARS-COV-2 IGM IS AN ENZYME IMMUNOASSAY METHOD WITH A FINAL FLUORESCENCE DETECTION (ELFA). THE SPECIFIC IMMUNOANALYSIS TECHNIQUE USED AT THE REFERENCE LABORATORY WAS NOT PROVIDED. THE COMPLAINT INVESTIGATION FOR FALSE POSITIVE RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, DEVICE HISTORY RECORDS, AND RETURN TESTING. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. DEVICE HISTORY RECORD REVIEW ON LOT 20611FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. IN-HOUSE SPECIFICITY 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. TWO ALIQUOTS OF SID 161315 WERE RETURNED. TESTING WAS PERFORMED FOR THE RETURNED PATIENT SAMPLES USING THE 6R87 IGM ASSAY, THE 6R86 IGG ASSAY AND THE 6S60 IGG II QUANT ASSAY. POSITIVE IGM RESULTS WERE OBTAINED FOR THE SAMPLES WHICH ALIGNED WITH THE CUSTOMERS OBSERVATION. IGG TESTING RETURNED NEGATIVE RESULTS WHEREAS POSITIVE RESULTS WERE OBTAINED USING THE IGG II QUANT ASSAY. IN THIS CASE, NO INFORMATION WAS PROVIDED IN RELATION TO DATE SINCE SYMPTOM ONSET OR PCR TESTING. POSITIVE IGM RESULTS WERE OBTAINED FOR THE RETURNED PATIENT SAMPLES ALIGNING WITH THE CUSTOMER¿S RESULTS FOR SID 161315. RESULT OF THAT SAMPLE ON THE VIDAS METHOD WAS ALSO POSITIVE. 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). 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

    PATIENT IDENTIFIER: SID: (B)(6). 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 6R87-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6R87-20/30. PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE POSITIVE SARS-COV-2 IGM RESULTS GENERATED ON THE ARCHITECT I1000SR PROCESSING MODULE FOR TWO SAMPLES. THE FOLLOWING DATA WAS PROVIDED: REFERENCE RANGE FOR ALL THREE METHODS: >/= 1.00 S/CO (1.00 INDEX) IS POSITIVE; SID: (B)(6) ON (B)(6) 2020; INITIAL RESULT = 1.84 INDEX (S/C), BIOMERIEUX MINIVIDAS = 0.57 S/CO, IMMUNOANAYSIS AT REFERENCE LABORATORY = 0.49 S/CO. SID: (B)(6); (B)(6) 2020; INITIAL RESULT = 4.37 INDEX (S/C), REPEATS = 4.79 S/CO AND 4.51 S/CO, BIOMERIEUX MINIVIDAS = 1.45 S/CO, IMMUNOANALYSIS AT REFERENCE LABORATORY = 0.38 S/CO NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203027 SARS-COV-2 IGM SARS-COV-2 IGM QKO ABBOTT IRELAND 20611FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC I2000SR RECONDIT SP, 03M74-96, ISR03190| ARC I2000SR RECONDIT SP, 03M74-96, ISR03190| ARC I2000SR RECONDIT SP, 03M74-96, ISR03190