MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2-IGG REAGENT KIT; REAGENT, CORONAVIRUS SEROLOGICAL

Model Number	06R8620
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.
Event or Problem Description
The customer reported a false negative architect sars-cov-2 igg result for a patient.The following data was provided on (b)(6) 2021 (reference range: < 1.40 s/c = negative, >/= 1.40 s/c = positive): sid (b)(6) = initial result = 1.33 s/c (negative), repeat result = 1.45 s/c (positive).The customer stated that the quality control for sars-cov-2 igg assay is running low but are still within range of the package insert.There was no impact to patient management reported.
Additional Manufacturer Narrative
(b)(4).The complaint investigation for false negative architect sars-cov-2 igg results included a search for similar complaints, and the review of complaint text, trending data, labeling, scientific literature and device history records.Return testing was not possible as returns were not available.Clinical specificity and sensitivity testing were performed using an in-house retained kit lot 23466fn00 stored at the recommended storage condition.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Device history record was reviewed on lot 23466fn00 did not show any non-conformances, or deviations relating the customers issue.Labeling was reviewed and found to adequately address the issue under review.In this case, the patient sample initially generated a sars-cov-2 igg result of 1.33 s/c (negative) and repeat result of 1.45 s/c (positive) with no additional information provided.To assess the clinical performance of 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).This study was based on a hospitalized/symptomatic population.Differences in antibody responses between populations, based on more severe versus less severe illness, are consistent with published reports, zhao j et al.2020.Antibody responses to sars-cov-2 in patients of novel coronavirus disease 2019.Medrxiv.Negative results do not rule out sars-cov-2 infection, particularly in those who have been in contact with the virus.Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.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.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, no systemic issue or deficiency of the architect sars-cov-2 igg, lot 23466fn00 was identified.Suspect medical device was updated including the phone number, email, and fax number.All manufacturers was updated including the mfg site email and mfg site fax number.
Additional Manufacturer Narrative
This follow up is submitted to populate with data that had previously been provided.There is no change to the content of the data.

• Brand Name: SARS-COV-2-IGG REAGENT KIT
• Common Device Name: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 11441048
• Report Number: 3008344661-2021-00058
• Device Sequence Number: 3539530
• Product Code: QKO
• UDI-Device Identifier: 00380740191832
• UDI-Public: 00380740191832
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2021

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 Expiration Date: 05/26/2021
• Device Model Number: 06R8620
• Device Catalogue Number: 06R86-20
• Device Lot Number: 23466FN00
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 06/14/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/13/2021; 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1