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

Model Number 06R9020

Device Problem False Negative Result (1225)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

A literature article by samantha ngamsuntikul, jose quesada, and rachel beddard, ¿sars-cov2 antibody testing: a comparison of two assay platforms to designate convalescent plasma as high titer¿, transfusion 61.Suppl 3: 154a-155a.Blackwell publishing inc.(sep 2021), documented false negative alinity i sars-cov-2 igg results for three donors who were resulted as high titer on the vitros assay.The aim of the study was to determine which platform (alinity i vs vitros) provided the most units that could be designated as high titer for patient use.Per the article: covid-19 convalescent plasma was deployed as an early therapeutic with our center starting collections in april of 2020.The fda subsequently required the labeling of these units as high or low titer per minimum antibody cutoff levels for each authorized assay.Because of the center's affiliation with a sister organization that performs blood and plasma center testing, we had access to two different platforms for quantitative covid-19 antibody testing.Between october 2020 and january 2021, 233 paired convalescent plasma donor samples were tested for antibody levels using the anti-sars-cov-2 igg assay on the vitros (ortho clinical diagnostics) and the sars-cov-2 igg assay on the alinity i (abbott diagnostics).The study data was grouped into nonreactive, low tier, and high titer per fda cutoffs.There were three donors who tested as nonreactive on the alinity i but resulted as high titer on the vitros.There was one donor who tested as a low titer on the alinity i but resulted as negative on the vitros.Out of the 233 samples, 7 were nonreactive, 118 were low titer, and 108 were high titer on the alinity i.Out of the 233 samples, 3 were reactive, 78 were low titer, and 152 were high titer on the vitros.No impact to patient management was reported.

Event Description

A literature article by samantha ngamsuntikul, jose quesada, and rachel beddard, ¿sars-cov2 antibody testing: a comparison of two assay platforms to designate convalescent plasma as high titer¿, transfusion 61.Suppl 3: 154a-155a.Blackwell publishing inc.(sep 2021), documented false negative alinity i sars-cov-2 igg results for three donors who were resulted as high titer on the vitros assay.The aim of the study was to determine which platform (alinity i vs vitros) provided the most units that could be designated as high titer for patient use.Per the article: covid-19 convalescent plasma was deployed as an early therapeutic with our center starting collections in april of 2020.The fda subsequently required the labeling of these units as high or low titer per minimum antibody cutoff levels for each authorized assay.Because of the center's affiliation with a sister organization that performs blood and plasma center testing, we had access to two different platforms for quantitative covid-19 antibody testing.Between october 2020 and january 2021, 233 paired convalescent plasma donor samples were tested for antibody levels using the anti-sars-cov-2 igg assay on the vitros (ortho clinical diagnostics) and the sars-cov-2 igg assay on the alinity i (abbott diagnostics).The study data was grouped into nonreactive, low tier, and high titer per fda cutoffs.There were three donors who tested as nonreactive on the alinity i but resulted as high titer on the vitros.There was one donor who tested as a low titer on the alinity i but resulted as negative on the vitros.Out of the 233 samples, 7 were nonreactive, 118 were low titer, and 108 were high titer on the alinity i.Out of the 233 samples, 3 were reactive, 78 were low titer, and 152 were high titer.Null.

Manufacturer Narrative

The complaint investigation for false negative results for three donors with the sars-cov-2 igg assay on the alinity i processing module included a review of data and information of the article ¿sars-cov2 antibody testing: a comparison of two assay platforms to designate convalescent plasma as high titer¿, ticket trending review, labeling review, device history record, and in-house testing.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any related non-conformances or deviations with list number 06r90 and the complaint issue.As the likely cause lot number was unknown, testing was performed on a representative reagent lot.Specificity and sensitivity testing was performed using an in-house retain kit of lot 22469fn00.All specifications were met indicating the assay is performing acceptably in the field.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the sars-cov-2 igg assay, lot number unknown was identified.Section g1 has been updated to current contact information.

• Brand Name: SARS-COV-2 IGG REAGENT KIT
• 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: 12863285
• MDR Text Key: 283789331
• Report Number: 3008344661-2021-00206
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 00380740192129
• UDI-Public: 00380740192129
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 06R9020
• Device Catalogue Number: 06R90-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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, 03R65-01, 205UNKNOWN01; ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWN01