MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SARS-COV-2 IGG II; IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number C69057

Device Problem False Negative Result (1225)

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

Event Date 12/29/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 the customer reported repeatable non-reactive sars-cov-2 igg ii (access sars-cov-2 igg ii assay, part number c69057, lot number not provided) and sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 172108) results were generated for one patient on the customer's unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(4)).The customer reported reactive results using vitros 5600 cov2g assay.This report address the repeatable non-reactive sars-cov-2 igg ii results.A second report will address the non-reactive access sars-cov-2 igg results.On (b)(6) 2021, the access sars-cov-2 igg results were 0.66 s/co (non-reactive: <1.0 s/co), repeated at 0.75 s/co the day after.The access sars-cov-2 igg ii result was also non-reactive at 6.47 au/ml (non reactive: < 10 au/ml) on (b)(6) 2021.A second sample from the same patient gave similar results.On (b)(6) 2021 the access sars-cov-2 igg results were 0.67 s/co, repeated at 0.66 s/co the day after.The access sars-cov-2 igg ii result was also non-reactive at 6.44 au/ml on (b)(6) 2021.On (b)(6) 2021, both samples were tested using vitros 5600 cov2g assay with discordant reactive results (sample one: 14.0 and sample two: 14.6).No affect to patients or end-users has been reported in connection with this event.The customer did not provide information on patient symptoms, vaccination, or pcr (polymerase chain reaction) or covid antigen test results.No further information was provided.No hardware errors or issues with other assays were reported in conjunction with this event.A passing system check was obtained on (b)(6) 2021.The customer did not provide calibration or qc data for sars-cov-2 igg ii.There were no issues with sample integrity reported by the customer.Sample collection, handling and processing information such as sample type, sample volume collected, centrifugation, storage and other sample related information was not provided by the customer.

Manufacturer Narrative

The fill patient identifier is (b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The customer did not supply sars-cov-2 igg ii reagent lot number.No expiration date, udi or device manufactured date could be provided.The access sars-cov-2 igg ii reagent was not returned for evaluation.No hardware errors or other assay issues were reported in conjunction with this event.Sars-cov-2 is an enveloped non-segmented positive-sense rna virus.It has several structural proteins including spike (s), envelope (e), membrane (m) and nucleocapsid (n).The spike protein (s) contains a receptor binding domain (rbd) which is responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ace2).It is found that the rbd of the sars-cov-2 s protein strongly interacts with the human ace2 receptor leading to endocytosis into the host cells and viral replication.The access assay detect antibodies directed against the spike protein, which are more likely to neutralize the virus.No manufacturer guarantees both a specificity and sensitivity of 100%.The concentration of sars-cov-2 igg in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, diversity of antibodies and reagent specificity.Differences in each individual assay are expected.In conclusion the cause of the discordant results could not be determined with the available information.Values obtained with different assay methods should not be used interchangeably and difference between methods are expected.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

• Brand Name: ACCESS SARS-COV-2 IGG II
• Type of Device: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 13343044
• MDR Text Key: 289008878
• Report Number: 2122870-2022-00003
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C69057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/29/2021
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1