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	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fill patient identifier is (b)(6).Nine (9) patients are included in this event.The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sars-cov-2 igg ii reagent was not returned for evaluation.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 at the time of the event.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.Per the roche ¿elecsys anti-sars-cov-2 s¿ instructions for use (09289267501v0.6) the antigens within the reagent captures predominantly anti-sars-cov-2 igg, but also anti-sars-cov-2 iga and igm¿ and ¿due to the diversity of the antibodies, the measured anti-sars-cov-2-s value can vary depending on the testing procedure used and the applied standard.Results obtained from a single sample using tests from different manufacturers can therefore differ.¿ a decline in the antibody response has been documented in several publications: seow j, graham c, merrick b, et al.Longitudinal observation and decline of neutralizing antibody responses in the three months following sars-cov-2 infection in humans.Nat microbiol.2020, 5:1598¿1607.Patel mm, thornburg nj, stubblefield wb, et al.Change in antibodies to sars-cov-2 over 60 days among health care personnel in nashville, tennessee.Jama.2020;324(17):1781¿1782.Doi:10.1001/jama.2020.18796.No manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.Per the sars-cov-2 igg ii instructions for use (ifu), part number (pn) c69158 a ¿currently no reference standard is available for this assay.¿ ¿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 and reagent specificity.Values obtained with different assay methods should not be used interchangeably.¿ although seroconversions and decline in antibody levels may explain some of the discordance observed, the cause of this event cannot be determined with the available information.Values obtained with different assay methods should not be used interchangeably as differences are expected.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
Event or Problem Description
On (b)(6) 2021 the customer reported discordant non-reactive sars-cov-2 igg ii (access sars-cov-2 igg ii assay, part number c69057, lot number 922896) results were generated for several patients on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)).Fifty-one (51) patient samples were tested on the access sars-cov-2 igg ii assay and compared to the roche elecsys anti-sars-cov-2 s and the ortho vitros sars-cov-2 igg assay.Eighteen (18) samples are suspected to be false non-reactive.No clinical data was available.Refer to relevant tests section below.Six (6) medwatch reports will be generated to address customer reports of discordant non-reactive access sars-cov-2 igg ii results obtained on different dates.This report address the discordant non-reactive access sars-cov-2 igg ii patient results obtained on (b)(6) 2021.Medwatch number ¿2122870-2021-00034¿ will address discordant reactive access sars-cov-2 igg ii patient results obtained on (b)(6) 2021.Medwatch number ¿2122870-2021-00035¿ will address discordant reactive access sars-cov-2 igg ii patient result obtained on (b)(6) 2021.Medwatch number ¿2122870-2021-00036¿ will address discordant reactive access sars-cov-2 igg ii patient results obtained on (b)(6) 2021.Medwatch number ¿2122870-2021-00037¿ will address discordant reactive access sars-cov-2 igg ii patient result obtained on (b)(6) 2021.Medwatch number ¿2122870-2021-00039¿ will address discordant reactive access sars-cov-2 igg ii patient result obtained on (b)(6) 2021.No affect to patients or end-users has been reported in connection with this event.The customer did not indicate if the result was released outside the laboratory.No hardware errors were reported in conjunction with this event.Calibration passed on 9feb2021.Quality control (qc) was passing within the laboratory¿s established ranges.System check passed on 3mar2021.Arcdata analysis for the csv data file provided was unremarkable and did not highlight a performance issue.There were no issues with sample integrity reported by the customer.Sample collection, handling and processing information such as sample type, sample volume collected, centrifugation, storage and other sample related 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: 11567480
• Report Number: 2122870-2021-00038
• Device Sequence Number: 3521678
• Product Code: QKO
• UDI-Device Identifier: 15099590742744
• UDI-Public: (01)15099590742744(17)210531(11)201201(10)922896
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/25/2021

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: 922896
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1