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 Insufficient Information (4580)

Event Date 01/17/2022

Event Type  malfunction  

Event Description

On 17jan2022 the customer reported non-reactive covid igg (access sars-cov-2-igg ii, part number c69057 and lot number 124814) results were generated on the customer's dxi (unicel dxi 800 access immunoassay analyzer, part number 973100 and serial number 606051) for two patients.The non-reactive patient results were discordant to results generated using the sars-cov-2 igg ii quant abbott architect method.There was no report of change to patient care or treatment in connection with this event.The customer reported that the patients had been vaccinated against sars-cov-2, and had received supplemental doses of covishield vaccinations (specific dates of vaccinations were not provided).No other patient information was provided.The event log was provided showing substrate dispense errors which occurred before the issue occurred.System check was passing within specifications at the time of the event.It was noted that the customer was using a calibration which had flags indicating substrate reagent was expired at the time of calibration.The customer was not running quality control 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.

Manufacturer Narrative

The full identifier is (b)(4).The customer did not provide patient demographics such as age, date of birth, gender, weight, ethnicity or race.The access sars-cov-2 igg ii 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.A beckman coulter field service engineer (fse) was dispatched to the customer site to assess system performance.Fse proactively replaced duck bill valve and aspirate probes.Fse performed calibration and verified some samples.No assay issue or any hardware issues were found.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.In conclusion, the cause of this event cannot be determined with the available information.

• 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 ; 1000 lake hazeltine drive; chaska, MN 55318 ; 7149613625
• MDR Report Key: 13351297
• MDR Text Key: 294661062
• Report Number: 2122870-2022-00004
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590742744
• UDI-Public: (01)15099590742744(17)220331(11)211001(10)124814
• 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 Expiration Date: 03/31/2022
• Device Catalogue Number: C69057
• Device Lot Number: 124814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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