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

Catalog Number C58961

Device Problem False Negative Result (1225)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 the customer reported non-reactive covid igg results (access sars-cov-2 igg, part number c58961, lot number not provided) were generated on the customer's dxi 800 analyzer (dxi 800 access immunoassay analyzer, part number 973100 and serial number (b)(4)) for an unspecified number of patients.The customer did not indicate whether the results were released from the laboratory.The customer did not report a change to patient care of treatment in connection with this event.The customer reported that the patients had been vaccinated against sars-cov-2; however, customer did not provide vaccination dates or specific vaccination administered.The customer also noted the patients had a previous history of testing pcr positive for sars-cov-2 (specific pcr assay not provided).No hardware errors were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control not provided for review.No issues with sample integrity were reported by the customer.Sample collection, handling and processing information such as sample type, sample volume collected, sample quality, centrifugation time and speed, storage temperature and other information was not provided by the customer.

Manufacturer Narrative

(b)(6) the customer did not provide patient demographics such as age, date of birth, gender, weight, ethnicity or race.The customer did not provide an access sars-cov-2 igg assay lot number; therefore, a date of expiration and udi are not available.The customer did not provide an access sars-cov-2 igg assay lot number; therefore, a date of manufacture is not available.The access sars-cov-2 igg assay was not returned for evaluation.There were no reports of system issues at the time of the event.There was no report of issues with other assays at the time of the event.No hardware errors or flags were reported in conjunction with the 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 detects 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.Different vaccines do not elicit the same immune response and each patient response is different therefore differences in patient responses are expected after vaccination.The access assay is not labeled for vaccine response detection.Additionally, per safety communication from fda on 19may2021, antibody testing is not currently recommended to assess immunity after covid-19 vaccination.In conclusion, the cause of this event is likely due to use error.

• Brand Name: ACCESS SARS-COV-2 IGG ASSAY
• Type of Device: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12162833
• MDR Text Key: 280572307
• Report Number: 2122870-2021-00103
• 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,u
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C58961
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1