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

Catalog Number 06S60-23

Device Problem False Negative Result (1225)

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

The customer obtained false negative architect sars-cov-2 igg ii quant results for 2 patients after receiving 2 doses of the covid vaccine.The following data was provided (reference range: < 50.0 au/ml is negative, >/= 50 au/ml is positive) sample 1 = sars-cov-2 igg ii quant result = 0.1 au/ml.Sample 2 = sars-cov-2 igg ii quant result = 0.6 au/ml.No patient information was provided by the customer.There was no impact to patient management reported.

Manufacturer Narrative

This report is being filed on an international product, list number 06s60-23 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s60-20/-30 or (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.

Manufacturer Narrative

The complaint investigation for false 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.The lot search review did not identify an increase in complaint activity for the issue.Performance testing was completed using an in-house retain kit of complaint lot 30303fn00.All specifications were met indicating the lot is performing acceptably.Device history records were reviewed and did not identify any non-conformances or deviations.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.Product labeling also documents that the persistence of a sars-cov-2 immune response has not been fully established.Negative results may be observed due to a decline in antibody titer over time.In this case, no specific patient information was provided.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 reagent lot 30303fn00 is performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igg ii quant reagent was identified.B5 - describe event or problem initial: the customer obtained false negative architect sars-cov-2 igg ii quant results for 2 patients after receiving 2 doses of the covid vaccine.The following data was provided (reference range: < 50.0 au/ml is negative, >/= 50 au/ml is positive) sample 1 = sars-cov-2 igg ii quant result = 0.1 au/ml sample 2 = sars-cov-2 igg ii quant result = 0.6 au/ml no patient information was provided by the customer.There was no impact to patient management reported.

Event Description

The customer obtained false negative architect sars-cov-2 igg ii quant results for one patient after receiving 2 doses of the covid vaccine.The following data was provided (reference range: < 50.0 au/ml is negative, >/= 50 au/ml is positive).Sample 1 = sars-cov-2 igg ii quant result = 0.1 au/ml.Sample 2 = sars-cov-2 igg ii quant result = 0.6 au/ml.No patient information was provided by the customer.There was no impact to patient management reported.

• 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
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12642663
• MDR Text Key: 281910504
• Report Number: 3008344661-2021-00186
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2021
• Device Catalogue Number: 06S60-23
• Device Lot Number: 30303FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(4); ARC I2K PROC MOD, 03M74-01, (B)(4)