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 False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Date 11/11/2021

Event Type  malfunction  

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.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.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.Per fda safety communication on 19-may-2021 ¿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.¿ the local support organization discussed that the results are not comparable in conclusion, the cause of this event cannot be determined with the available information.This event is part of field action (b)(4).

Event Description

On (b)(6) 2021 the customer reported non-reactive (below cut-off of 30 iu/ml) covid (access sars-cov-2 igg 1st is assay, part number c74339, lot number not provided) results were generated on the customer's unicel dxi 600 access immuno analyzer (part number a30260 and serial number (b)(4)).Customer reported the patient sample, when tested on alternate platform (abbott) (specific assay information not provided) the abbott platform generated a reactive result (above the cut-off of 50 au/ml).Specific test results information not provided for either beckman or abbott assay results.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.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.Per customer's verbal report, qc was passing within specifications at the time of the event.The customer also reported an external qc survey also passed.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
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN ; 9523681224
• MDR Report Key: 12856367
• MDR Text Key: 285691484
• Report Number: 2122870-2021-00172
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: C74339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-2508-2021
• Patient Sequence Number: 1