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

Catalog Number 06R90-23

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06r90-23 (sars-cov-2 igg) that has a similar product distributed in the us, list number 06r90-20 (sars-cov-2 igg), eua (b)(4).

Event Description

The customer observed a false negative sars-cov-2 igg result for one patient on an alinity i analyzer, when compared to another assay.The following data was provided (<1.4 index (s/c) is negative, >/=1.4 index (s/c) is positive): initial result was 1.11 index (s/c); the igg ii result was >40,000.00 au/ml, which is positive.It was noted that the patient was treated for covid-19 in late september and was discharged from the hospital with a negative pcr test.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false negative alinity sars-cov-2 igg results included a search for similar complaints, the review of complaint text, trending data, labeling, scientific literature, and device history records.Sensitivity and specificity testing was done using an in-house retained kit of lots 31123ud00 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 the lot number did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The customer reported a false negative result for a patient when testing was performed using alinity sars-cov-2 igg reagent lot 31123ud00, compared to another method (iggii).The initial result was 1.11 index (s/c); the igg ii result was >40,000.00 au/ml, which is positive.It was noted that the patient was treated for covid-19 in late september and was discharged from the hospital with a negative pcr test.In this case, the samples were collected from 2 of the patients 49 and 57 days after the pcr positivity.According to the ¿report from the american society for microbiology covid-19 international summit, 23 march 2020: value of diagnostic testing for sars-cov-2/covid-19.Mbio 11:e00722-20¿, patel r, et al, it is unknown for certain whether individuals infected with sars¿cov-2 who subsequently recover will be protected, either fully or partially, from future infection with sars¿cov-2 or how long protective immunity may last.The study ¿clinical and immunological assessment of asymptomatic sars-cov-2 infections, nature medicine¿, quan-xin long, et al, showed that antibodies declined in both asymptomatic and symptomatic covid-19 patients during the early convalescence phase.It was observed that igg levels and neutralizing antibodies in a high proportion of individuals who recovered from sars-cov-2 infection start to decrease within 2-3 months after infection.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.Review of the manuscript ¿performance characteristics of the abbott architect sars-cov-2 igg assay and seroprevalence in boise, idaho¿, bryan et al.2020, 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.Per the limitations of the procedure section of the package insert, alinity sars-cov-2 igg 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.Negative results do not rule out sars-cov-2 infection, particularly in those who have been in contact with the virus.Based on the investigation, alinity sars-cov-2 igg reagent, lot number 31123ud00, is performing as intended, no systemic issue or deficiency of the reagent was identified.Section g1 - contact office information updated.

• Brand Name: SARS-COV-2 IGG
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford, IL N39 E-932 ; 2246682940
• MDR Report Key: 12938601
• MDR Text Key: 285689502
• Report Number: 3008344661-2021-00209
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2021
• Device Catalogue Number: 06R90-23
• Device Lot Number: 31123UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, (B)(6) ; ALNTY I PROCESSING MODU, (B)(6)