MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SARS-COV-2 IGG ASSAY; 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	07/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 the customer reported negative covid igg results (access sars-cov-2 igg, part number c58961 and lot number 124130) were generated on the customer's dxi (unicel dxi 800 access analyzer, part number a71457 and serial number (b)(4)) for one patient.The customer reported the results were released from the laboratory.The customer reported there was no change to patient treatment in conjunction with the event.The customer reported the patient sample had generated nonreactive results with a different methodology (abbott sars cov 2 igg) but generated positive results with a sars-cov-2 total ab, s protein assay (manufacturer unknown).The customer also reported the patient had previously been vaccinated with the johnson and johnson sars-cov-2 vaccine, administered on (b)(6) 2021.No hardware errors were reported in conjunction with this event.System performance indicators such as system check, calibration and quality control were passing within specifications at the time of the event.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.
Additional Manufacturer Narrative
(b)(6).The customer did not provide patient demographics such as age, date of birth, weight, ethnicity or race.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.All assay and system verifications met specifications 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 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.The access sars-cov-2 igg assay is not labeled for vaccine response detection.The performance of our serology assays has not been established in individuals that have received a covid-19 vaccine.Depending upon the vaccine administered, the antibodies generated may be different and therefore the test result may differ depending upon the specific antibody being detected by the assay in use in the laboratory.Different vaccines do not elicit the same immune response and each patient response is different therefore differences in patient responses are expected after vaccination.Per fda safety communication on 19may2021 ¿results from currently authorized sars-cov-2 antibody tests should not be used to evaluate a person¿s level of immunity or protection from covid-19 at any time, and especially after the person received a covid-19 vaccination.While a positive antibody test result can be used to help identify people who may have had a prior sars-cov-2 infection, more research is needed in people who have received a covid-19 vaccination.¿ in conclusion, the cause of the event is use error.The customer was using the sars-cov-2 assay off-label; the access sars-cov-2 igg assay is not labeled for vaccine response detection.

• Brand Name: ACCESS SARS-COV-2 IGG ASSAY
• Common Device Name: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12299891
• Report Number: 2122870-2021-00123
• Device Sequence Number: 3970396
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210930(11)210202(10)124130
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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: 09/30/2021
• Device Catalogue Number: C58961
• Device Lot Number: 124130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1