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

Catalog Number 06S61-22

Device Problem False Negative Result (1225)

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

Event Date 02/16/2022

Event Type  malfunction  

Event Description

The customer observed false negative sars-cov-2 igg results generated on the alinity i processing module for one patient who had a positive covid 19 self-test in january and is not vaccinated.The following data was provided (reference ranges: sars-cov-2 igg results >/= (b)(6) s/co is positive, sars-cov-2 igg ii quant results >/= (b)(6) au/ml is positive): (b)(6) 2022 : sars-cov-2 igg = (b)(6) s/co, sars-cov-2 igg ii quant = (b)(6) au/ml (b)(6) 2022 sid (b)(6) : sars-cov-2 igg ii quant = (b)(6) au/ml.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6s61-22 (sars-cov-2 igg ii quant ) and has a similar product distributed in the us, list number 6s61-20/-30 (advisedx sars-cov-2 igg ii: eua # 203119).

Manufacturer Narrative

The complaint investigation for false negative 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 completed as returns were not available.In-house specificity and sensitivity testing for reagent lot 36068fn00 was completed using a retained sample of the complaint lot.All specifications were met indicating the lot is performing acceptably.Device history record review on lot 36068fn00 did not show any potential non-conformances, or deviations associated with the complaint issue.Labeling was reviewed which adequately address the issue under review.In this case, no specific patient information was provided in terms of immunocompromisation.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.The sars-cov-2 igg ii quant assay is designed to detect immunoglobulin class g (igg) antibodies, including neutralizing antibodies, to the receptor binding domain (rbd) of the s1 subunit of the spike protein, whereas the sars-cov-2 igg assay is designed to detect igg antibodies to the nucleocapsid protein of sars-cov-2.In this case, the patient may have a stronger response to the nucleocapsid protein.It is noted that the sars-cov-2 igg ii results although negative are elevated.No details regarding patient symptoms were provided.Per product labeling, higher titer antibody responses have been observed in patients with more severe illness as compared with mildly symptomatic or asymptomatic individuals.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.In this case no specific patient data was provided.Per the clinical performance section of the package insert, the assay sensitivity (ppa) at = 15 days post-positive pcr is 98.70% (95 % ci 93.00, 99.93).When immunocompromised specimens were included in the assessment, the observed ppa at = 15 days post-positive pcr result was 95.45% (95% ci: 88.89, 98.22).Results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.Negative results do not rule out sars-cov-2 infection, particularly in those who have been in contact with the virus.Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.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.Based on the investigation sars-cov-2 igg ii quant reagent lot 36068fn00 is performing as intended, no systemic issue or deficiency of the sars-cov-2 igg ii quant reagent was identified.

Event Description

The customer observed false negative sars-cov-2 igg results generated on the alinity i processing module for one patient who had a positive covid 19 self-test in january and is not vaccinated.The following data was provided (reference ranges: sars-cov-2 igg results >/= 1.40 s/co is positive, sars-cov-2 igg ii quant results >/= 50 au/ml is positive) (b)(6) 2022: sars-cov-2 igg = 2.44 s/co, sars-cov-2 igg ii quant = 30 au/ml 18mar2022 sid (b)(6): sars-cov-2 igg ii quant = 34 au/ml no impact to patient management was reported.

• Brand Name: SARS-COV-2 IGG II QUANT 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 N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13932513
• MDR Text Key: 290297374
• Report Number: 3008344661-2022-00024
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Catalogue Number: 06S61-22
• Device Lot Number: 36068FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2021
• 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, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6)