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 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

(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.The patient sample was submitted to the beckman coulter complaint handling unit (chu) for testing.The chu obtained one non-reactive and one reactive result as the result was close to the cut-off of the assay, close to the results obtained by the customer.The chu then tested the sample with the sars-cov-2 igg 1st is assay.Non-reactive results were generated, suggesting the sample is non-reactive for sars-cov-2.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.Different vaccines were placed on the market and do not elicit the same immune response.The roche assay is a total assay, detecting igg, igm and iga without distinction.The results of a total assay cannot be compared to the results of an ¿igg-only¿ assay.Additionally, the access sars-cov-2 igg ii assay is not currently labelled for vaccine response detection and is not currently standardized against the international standard.The performances of the access sars-cov-2 igg ii or access sars-cov-2 igg (1st is) assays have not been established in individuals that have received a covid-19 vaccine.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 cannot be determined with the available information.

Event Description

On (b)(6) 2021 the customer reported non-reactive covid igg results (access sars-cov-2 igg ii, part number c69057, lot number 124558) were generated on the customer's dxi (dxi 800 access immunoassay analyzer, part number 973100 and serial number (b)(4)).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 patient had been vaccinated against sars-cov-2 with the astrazeneca vaccine in early june.Customer reported the patient had a reactive covid result with a sample collected (b)(6) 2021 and tested on the roche anti-sars-cov-2 s total method on (b)(6) 2021.The customer also reported a sample collected and tested on (b)(6) 2021 and tested using the access covid igg assay had also had a nonreactive result.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 ad the time of the event.No issues with sample integrity were reported by the customer.Sample was noted to be collected in a 5 ml bd vacuette serum tube with clot activators.It was noted to be a full draw and allowed to clot for >30 minutes; centrifuged sample was noted to be clear.Centrifugation time and speed not provided.

• 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: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12318689
• MDR Text Key: 267292283
• Report Number: 2122870-2021-00128
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590742744
• UDI-Public: (01)15099590742744(17)211031(11)210503(10)124558
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: C69057
• Device Lot Number: 124558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1