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 Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 the customer reported non-reactive sars-cov-2 igg (1st is) (access sars-cov-2 igg (1st is) assay, part number c74339, lot number 124756) results were generated for one vaccinated patient on the customer's unicel dxi 600 access immunoassay analyzer (part number a30260 and serial number (b)(4)).An initial non-reactive sars-cov-2 igg 1st is patient result was at 3.39 bau/ml on (b)(6) 2021.The result was discordant with an alternate method (82.75 bau/ml, for a cut-off at 0.80).The alternate method used by the customer is directed against the full spike protein of the sars-cov-2.The patient had been vaccinated with the astrazeneca vaccine and had received her second dose on (b)(6) 2021 (5 months before sample collection).A second non-reactive sars-cov-2 igg 1st is result was obtained for this patient the week of (b)(6) 2021.There was no report of an injury or illness to the patient attributable to the output from the device in this event.No hardware errors or issues with other assays were reported in conjunction with this event.System check passed on (b)(6) 2021.Calibration passed on (b)(6) 2021 with reagent lot 124756 and calibrator lot 124760.Quality control (qc) was passing within the laboratory¿s established ranges.One patient sample was sent to the marseilles chu (complaint handling unit) for investigation.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.Two (2) medwatch reports will be generated to address the two different dates of questioned results: medwatch number ¿2122870-2021-00178¿will address result obtained on (b)(6) 2021; medwatch will address result obtained the week of (b)(6) 2021.

Manufacturer Narrative

The fill patient identifier is (b)(6).The customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.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.The alternate method used by the customer is directed against the full spike protein of the sars-cov-2.One patient sample was sent to the marseilles chu for investigation.Patient sample was first tested neat for the sars-cov-2 igg 1st is assay.The marseilles chu obtained a non-reactive sars-cov-2 igg 1st is result.Customer's results were therefore confirmed.A decline in the antibody response over time may explain the non-reactive results obtained.This decline in neutralizing antibodies can start as early as three months after infection or vaccination.This decline 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.Einav g.Levin, m.D., yaniv lustig, ph.D., carmit cohen et al.Waning immune humoral response to bnt162b2 covid-19 vaccine over 6 months.The new england journal of medicine.2021; doi: 10.1056/nejmoa2114583.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.The access assays is not labelled for vaccine response detection.The performance of our serology assays has not been established in individuals that have received a covid-19 vaccine.Depending upon the vaccine administered, the antibodies generated may be different and therefore the test result may differ depending upon the specific antibody being detected by the assay in use in the laboratory.In conclusion, a cause for this event could not be determined with the information supplied.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

• 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 55318 ; 9523681224
• MDR Report Key: 12935094
• MDR Text Key: 286934533
• Report Number: 2122870-2021-00179
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590746919
• UDI-Public: (01)15099590746919(17)211231(11)210703(10)124756
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: C74339
• Device Lot Number: 124756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/19/2021
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/03/2021
• 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
• Patient Sex: Female