MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2 IGG II QUANT REAGENT KIT; SARS-COV-2 LGG

Catalog Number 06S60-22

Device Problem False Negative Result (1225)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).All available patient information is included.Additional patient details are not available.This report is being filed on an international product, list number 06s60-22 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s60-20 (advisedx sars-cov-2 igg ii), (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported false negative architect sars-cov-2 igg ii quant.Results for 2 patients after receiving the covaxin vaccine.The patients had received the vaccinations in (b)(6) 2021.The 2 patients were tested on (b)(6) 2021 and generated sars-cov-2 igg ii quant.Results of 5.7 au/ml and 34.0 au/ml.The doctor was questioning whether these patients were immune and whether the vaccine was effective.On (b)(6) 2021, the customer provided additional patient information for false negative architect sars-cov-2 igg ii quant.Results for 5 patients after receiving the 2nd dose of the covaxin vaccine.The following data was provided (reference range: < 50 au/ml is negative, >/= 50 au/ml is positive): (b)(6) (34.0 au/ml) / (b)(6) (37.6 au/ml) / (b)(6) (7.0 au/ml) / (b)(6) (42.2 au/ml) / (b)(6) (12.6 au/ml) there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely negative architect sars-cov-2 igg ii quant results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.A lot search review did not identify an increase in complaint activity for the issue.Device history record was reviewed and determined no non-conformances or deviations were identified.Clinical specificity and sensitivity testing was performed using a retained kit of the complaint lot 28453fn00.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and adequately addresses the issue under review.The reason for the negative results is unclear.Per the limitations of the procedure section of the package insert, 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.In this case, no specific patient information was provided.All 5 patients returned negative igg ii results, however results for 3 of the samples were elevated indicating the patients produced an immune response.Covaxin® contains 6¿g of whole-virion inactivated sars-cov-2 antigen (strain: niv-2020-770).Covaxin® should be administered as two does on day 0 and day 28.Phase 3 clinical trial conducted in 25,800 participants, with an interim analysis results showing vaccine efficacy of 78%.Per the covaxin® package insert, it is not known whether individuals with impaired immune responsiveness, including individuals receiving immunosuppressant therapy, will elicit the same response as immunocompetent individuals to the vaccine regimen.Immunocompromised individuals may have relatively weaker immune response to the vaccine regime.Per product labeling, specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Such specimens may show either falsely elevated or depressed values when tested with assay kits such as sars-cov-2 igg ii quant that employ mouse monoclonal antibodies.Rheumatoid factor (rf) in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.Per the clinical performance section of the package insert, the assay sensitivity (ppa) at = 15 days post-symptom onset is 99.37% (95 % ci 96.50, 99.97).When immunocompromised specimens were included in the assessment, the observed ppa at = 15 days post-symptom onset was 97.02% (95% ci: 93.22, 98.72).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 igg ii quant, lot 28453fn00 is performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igg ii quant reagent was identified.

• Brand Name: SARS-COV-2 IGG II QUANT REAGENT KIT
• Type of Device: SARS-COV-2 LGG
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 12327334
• MDR Text Key: 266890228
• Report Number: 3008344661-2021-00158
• 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
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Catalogue Number: 06S60-22
• Device Lot Number: 28453FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR INTGR, 01L86-40, I1SR60931; ARC I1000SR INTGR, 01L86-40, I1SR60931