MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SARS-COV-2 IGG II; IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number	C69057
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.(b)(6).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.No hardware errors or flags were reported in conjunction with the event.Calibration was within specifications at the time of the event.One patient sample was submitted to beckman coulter for investigation.The patient sample was tested in duplicate with the sars-cov-2 igg ii assay; one reactive (10.21 au/ml) and one non-reactive (9.9 au/ml) result were obtained; the results were close to the assay cut-off value of 10 au/ml.The sample was then tested in duplicate using an internal sars cov-2 igg assay, standardized to who first international standard (nibsc code: 20/136); reactive results of 42.69 iu/ml and 42.15 iu/ml were obtained (non-reactive cut-off <30 iu/ml).It should be noted that this assay is not approved for commercialization and was used for investigation purposes only.It should be noted that the access sars-cov-2 igg ii is not labeled for vaccine response detection.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On 13apr2021 the customer reported that on (b)(6) 2021 and again on (b)(6) 2021, nonreactive covid igg ii (access sars-cov-2 igg ii, part number c69057 and lot number 124141) patient results (8.76 au/ml; cut-off 10 au/ml ((b)(6) 2021) and 9.17 au/ml; cutoff 10 au/ml ((b)(6) 2021) ) were generated on the customer's dxi 800 (unicel dxi 800 access immunoassay analyzer, part number 973100 and serial number (b)(4)) for one patient.There was no report of injury or illness to the patient in conjunction with this event.The patient sample was also tested on a competitor platform (roche method; results of 15.2 (units not provided) (cutoff not provided) were obtained on (b)(6) 2021).The patient had been vaccinated with the astrazeneca vaccine five weeks prior to testing.No hardware errors or issues with other assays were reported in conjunction with this event.Calibration was passing within specifications at the time of the event.Review of customer-supplied arcdata file was unremarkable and did not highlight a performance issue.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.

• Brand Name: ACCESS SARS-COV-2 IGG II
• 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: 11797941
• Report Number: 2122870-2021-00068
• Device Sequence Number: 17107379
• Product Code: QKO
• UDI-Device Identifier: 15099590742744
• UDI-Public: (01)15099590742744(17)210531(11)201201(10)124141
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

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: 05/31/2021
• Device Catalogue Number: C69057
• Device Lot Number: 124141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1