MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SARS-COV-2 IGG (1ST IS); IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number C74339

Device Problem Low Test Results (2458)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.No "expiration date", "udi" and "device manufacture date" could be provided as no lot number was supplied.The access sars-cov-2 igg (1st is) 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.The vidas assay also targets those antibodies.There have not been any studies yet comparing the access sars-cov-2-igg (1st is) assay to any other manufacturers.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.Results obtained with the access assay may not be used interchangeably with values obtained with different manufacturers¿ test methods.Per the who study, ¿establishment of the who international standard reference panel for anti-sars-cov-2 antibody¿, mattiuzzo et al., variability of quantitative results with the who 1st is is evident manufacturer to manufacturer and method to method.Variation amongst quantitative results of serology assays are expected even when traceable to the same who international standard.Some factors which may contribute to variability of inter-manufacturer results are affinity of the antibodies in positive samples, assay format, and clinical decision points for the assay.Although variability amongst quantitative results is expected, qualitative result should be in alignment with the results of manufacturers who also have a who traceable igg assay.There is no international consensus determining the protective antibody response for sars-cov-2.The access assay is not labelled 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.In conclusion, the cause of this event cannot be determined with the available information.This event is part of field action fa-21047.

Event Description

On (b)(6) 2021 the customer reported non-reactive covid (access sars-cov-2 igg 1st is assay, part number c74339, lot number not provided) results were generated for vaccinated patients on the customer's unicel dxi 800 access immuno analyzer (part number 973100 and serial number (b)(4)).Customer reported testing 22 patient samples with the access sars cov-2 igg 1st is assay and also with the vidas assay.Customer reported 8 of the samples gave non-reactive results with the vidas assay and 22 samples gave reactive results with the vidas assay.The customer reported that the non-reactive covid patient results were discordant with the vidas method.No data was provided by the customer.The customer did not report whether the non-reactive covid results were reported out of the laboratory.There was no report of change to patient treatment or management which occurred in connection with this event.Per customer verbal report the patients were vaccinated; however, vaccine manufacturer information and date(s) of vaccine administration were not provided.No hardware errors or issues with other assays were reported in conjunction with this event.No system check, calibration and quality control (qc) data was provided.There were no issues with sample integrity reported by the customer.Sample information such as sample collection tube used, centrifugation time and speed, storage or handling was not provided by the customer.

• Brand Name: ACCESS SARS-COV-2 IGG (1ST IS)
• 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: 12642521
• MDR Text Key: 281153331
• Report Number: 2122870-2021-00168
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/15/2021

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 Catalogue Number: C74339
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2508-2021
• Patient Sequence Number: 1