MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS SARS-COV-2 IGG; IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number	C58961
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fill patient identifier is case-(b)(6).The customer did not supply patient demographics such as date of birth, weight, ethnicity or race.The access sars-cov-2 igg reagent was not returned for evaluation.No error messages or issues with other assays were reported.There were no reports of hardware interventions performed or hardware parts replaced.The sars-cov-2 igg assay currently do not have an intended use for vaccine response monitoring.The performance of the sars-cov-2 igg assays has not been established in individuals that have received a covid-19 vaccine.The clinical significance of a positive or negative antibody result following covid-19 vaccination has not been established, and the results from these assays should not be interpreted as an indication or degree of protection from infection after vaccination.Vaccine response has not been tested with the beckman coulter reagents, nor is this part of the product intended use, however beckman coulter is currently involved in studies to gather data.Sars-cov-2 vaccines on the market vary with regard to their target immune response, with some vaccines targeted at generating sars-cov-2 igg to the rbd of the spike protein only and others targeted at generating a variety of the igg's, e.G.Igg's to the nucleocapsid and the spike protein.Depending upon the vaccine administered, the antibodies generated may be different and therefore the test result i.E.Reactive or non-reactive, may differ depending upon the specific antibody being detected by the assay in use in the laboratory.No manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.In conclusion, an assignable cause of the event cannot be determined with the available information.Values obtained with different assay methods should not be used interchangeably and differences between methods are expected.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
Event or Problem Description
On (b)(6) 2021 the customer reported one non-reactive sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 172017) result was generated for one vaccinated patient on the customer's unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(4)).The patient result for the sars-cov-2 igg assay was non-reactive at 0.73 s/co on (b)(6) 2021.On (b)(6) 2021, the coviprotect sars cov2 spike antibody quantitative result was positive at 68 bau/ml (biological reference interval: positive = 7.1).This test detects and estimates the amount of neutralizing antibodies.No vaccine's name and no vaccination dates were provided.No pcr test provided.No affect to patients or end-users has been reported in connection with this event.No hardware errors or other assay issues were reported in conjunction with this event.There were no reports of hardware interventions performed or hardware parts replaced.Arcdata analysis provided was unremarkable and did not highlight a performance issue.The patient result was cex flagged.Calibration passed on 03apr2021 with reagent lot 172017 and calibrator lot 922849.System check passed on 26may2021.Qc was passing within the laboratorys established ranges.No issues with sample integrity were reported by the customer.No further information was provided.

• Brand Name: ACCESS SARS-COV-2 IGG
• Common Device Name: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• MDR Report Key: 12148848
• Report Number: 9680746-2021-00045
• Device Sequence Number: 14579975
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)211008(11)210210(10)172017
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2021
• Device Catalogue Number: C58961
• Device Lot Number: 172017
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2021
• Initial Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR