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

Catalog Number 06R86-22

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2020

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 06r86-22, that has a similar product distributed in the us, list number 06r86-20.

Event Description

The customer observed false negative sars-cov-2 igg results for one patient, who had received the oxford covid-19 vaccine, on an architect i2000sr analyzer.The following data was provided: initial igg result was 0.02 index(s/c), repeats were 0.05 and 0.05 index(s/c), which is negative; when repeated on the vitros igg assay the result was 6.8, which is positive.The sample was positive for both igg and igm using a rapid test with immunochromatography methodology.The sample was tested using the total antibody vitros assay and the result was 64.40, <0.99 is nonreactive.Additional laboratory testing was provided: architect igm results were 0.12, 0.12 and 0.12 index(s/c).It was noted that the customer is only questioning the architect sars-cov-2 igg results.There was no impact to patient management reported.

Manufacturer Narrative

(b)(4).Was this device serviced by a third party? no.The complaint investigation for false negative architect sars-cov-2 igg results included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Sensitivity testing was done using an in-house retained kit of lot number 19483fn00, stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Return testing was not complete as return samples were not available.Device history record review on lot number 19483fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The customer observed a negative result when using architect sars-cov-2 igg, reagent lot number 19483fn00, for a patient who had received the (b)(6) vaccine (vaccination date was not provided).When the sample was repeated in triplicate it remained negative (0.02/0.05/0.05 index).This was discrepant with the positive result obtained using the vitros igg and total antibody methods (6.8 and 64.4 respectively; cutoff 0.99).A rapid test by wondfo was also positive.The customer also observed a negative architect sars-cov-2 igm result, however, when this was repeated in triplicate it was negative.The igm result is not being questioned.In this case, a direct comparison should not be made between the architect sars-cov-2 total assay and the vitros and wondfro methods.The architect sars-cov-2 igg is designed to detect immunoglobulin class g (igg) antibodies to the nucleocapsid protein of sars-cov-2 using a chemiluminescent immunoassay (cmia) method, whereas the vitros methods detect antibodies (igg, iga and igm) to the spike protein of sars-cov-2, and the wondfro method is a lateral flow immunoassay (lfia) method.The (b)(6) vaccine is a spike protein-based vaccine.Antibodies generated in response to this vaccine may not be detected using the abbott igg assay, as this targets the nucleocapsid proteins in the covid virus.The abbott igg ii assay is a quantitative assay designed to detect igg antibodies to the spike protein of the virus, therefore, it would be a more accurate test to monitor vaccine response to the (b)(6) vaccine.Study of the immune response to the different vaccines is ongoing but not enough information is available at this time.The product package inserts advise that results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.Per the product labelling the assay sensitivity within the 95% confidence level is 95.89%- 100.00%.Based on the investigation, architect sars-cov-2 igg, reagent lot number 19483fn00, is performing as intended, no systemic issue or deficiency of the reagent was identified.

Manufacturer Narrative

This follow up is submitted to populate fields d8 and/or h6 with data that had previously been provided in field.H10.There is no change to the content of the data.

• 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
• MDR Report Key: 11068940
• MDR Text Key: 252104035
• Report Number: 3008344661-2020-00142
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Catalogue Number: 06R86-22
• Device Lot Number: 19483FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, (B)(4); ARC I2000SR INST, 03M74-02, ISR63489