MAUDE Adverse Event Report: ABBOTT LABORATORIES SARS-COV-2 IGG

Model Number	06R8620
Medical Device Problem Codes	False Negative Result (1225); False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).No further information was provided.This incident is associated with a user report of the incident mw5094544.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
A nurse practitioner ((b)(6) female) obtained false negative architect sars-cov-2 igg results.The nurse practitioner indicated she had the classic symptoms and tested positive with np pcr swab.On (b)(6) 2020 sample id (b)(6) generated a negative result on architect.On (b)(6) 2020 a new sample (b)(6) generated negative results on both architect and diasorin.However, on (b)(6) 2020 a donation of convalescent plasma was positive for igg (method unknown).No impact to patient management was reported.
Additional Manufacturer Narrative
(b)(4).The evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The complaint investigation included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Labeling was reviewed and sufficiently addresses the customer's issue.Device history record review on list number 06r86 did not show any potential non-conformances, or deviations related to the customer observation.Performance testing using a retained sample of a representative lot (15016m800) indicates that the lot is performing acceptably.A representative lot (15016m800) was used for testing as the lot number was unknown.In this case, the patient tested negative on the architect sars cov-2 igg on (b)(6).The patient also tested negative on another method diasorin.However, on (b)(6) 2020 a donation of convalescent plasma was positive for igg (method unknown).Two different test methods obtained the same test results on the same date.A possible sero conversion may explain the positive test result on a later date.Per the product labeling the assay sensitivity within the 95% confidence level is 95.89%- 100.00%.Patients have different immune responses and the insert states that immunocompromised patients who have covid-19 may have a delayed antibody response and produce levels of antibody which may not be detected as positive by the assay.A study was performed using 122 serum and plasma specimens collected at different times from 31 subjects who tested positive for sars-cov-2 by a polymerase chain reaction (pcr) method and who also presented with covid-19 symptoms.The positive percent agreement (ppa) at >/= 14 days post-symptom onset is 100.00% (95% ci: 95.89, 100.00).Five specimens from 1 immunocompromised patient were excluded from the study.When the results from these specimens were included, the ppa at >/= 14 days post-symptom onset was 96.77% (95% ci: 90.86, 99.33.Additionally, review of the manuscript bryan et al.2020.Performance characteristics of the abbott architect sars-cov-2 igg assay and seroprevalence in boise, idaho, j.Clin.Microbiol, doi: 10.1128/jcm.00941-20, showed sensitivity data consistent with product labeling.125 patients who tested rt-pcr positive for sars-cov-2 for which 689 excess serum specimens were available was tested and it was found that sensitivity reached 100% at day 17 after symptom onset and day 13 after pcr positivity.Based on the investigation architect sars-cov-2 igg assay is performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igg reagent was identified.

• Brand Name: SARS-COV-2 IGG
• Common Device Name: COV-2 IGG
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 10179839
• Report Number: 1415939-2020-00055
• Device Sequence Number: 3599950
• Product Code: QKO
• UDI-Device Identifier: 00380740191832
• UDI-Public: 00380740191832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 06R8620
• Device Catalogue Number: 06R86-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 06/22/2020; 08/12/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 06/22/2020; 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR