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 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

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/-30.No further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false negative sars-cov-2 igm and sars-cov-2 igg results generated on the architect i1000sr processing module for two patients after they received the sputnik vaccine on (b)(6) 2020.The following data was provided (reference ranges: sars-cov-2 igm >/= 1.00 index is positive, sars-cov-2 igg >/= 1.4 index is positive): (b)(6) 2021.Male patient: sars-cov-2 igm = 0.06 index, sars-cov-2 igg = 0.05 index.Female patient: sars-cov-2 igm = 0.06 index, sars-cov-2 igg = 0.02 index.No impact to patient management was reported.

Manufacturer Narrative

H6: health effect impact code: f26 h6: component code: g01003 d8: was this device serviced by a third party? no the complaint investigation for false negative architect sars-cov-2 igm and 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 completed as returns were not available.In-house sensitivity testing for reagent lots 20224fn00 and 20626fn00 were completed using retained kits of the complaint lots.All specifications were met indicating the lots are performing acceptably.Device history record review on lots 20224fn00 and 20626fn00 did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.In this case, negative igm and igg results were obtained for two patients 12 days after they had received the first dose of the sputnik v covid-19 vaccine.The sputnik vaccine uses a heterologous recombinant adenovirus approach using adenovirus 26 (ad26) and adenovirus 5 (ad5) as vectors for the expression of the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) spike protein, ¿sputnik v covid-19 vaccine candidate appears safe and effective¿, www.Thelancet.Com, published online february 2, 2021 https://doi.Org/10.1016/s0140-6736(21)00191-4.The sars-cov-2 igm assay is designed to detect immunoglobulin class m (igm) antibodies to the spike protein of sars-cov-2.However, the sars-cov-2 igg assay is designed to detect immunoglobulin class g (igg) antibodies to the nucleocapsid protein of sars-cov-2.Per the clinical performance section of the igg package insert, assay sensitivity (ppa) is 100.00% (95% ci: 95.89, 100.00).Per the clinical performance section of the igm package insert, assay sensitivity (ppa) is 96.67% (95% ci: 90.65, 98.86).Per the limitations of the procedure section of both package inserts, 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 assays.Results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.Based on the investigation architect sars-cov-2 igm reagent lot 20626fn00 and architect sars-cov-2 igg reagent lot 20224fn00 are performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igm or architect sars-cov-2 igg reagents were 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: 11237548
• MDR Text Key: 229805759
• Report Number: 3008344661-2021-00024
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2021
• Device Catalogue Number: 06R86-22
• Device Lot Number: 20224FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC COV2 IGM 100T OUS, 06R87-22, 20626FN00; ARC COV2 IGM 100T OUS, 06R87-22, 20626FN00; ARC COV2 IGM 100T OUS, 06R87-22, 20626FN00; ARC I1000SR MOD, 01L86-01, I1SR52220; ARC I1000SR MOD, 01L86-01, I1SR52220; ARC I1000SR MOD, 01L86-01, I1SR52220