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 08/25/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 the customer reported one unexpected low reactive sars-cov-2 igg (1st is) (access sars-cov-2 igg (1st is) assay, part number c74339, lot number 124628) result was generated for one vaccinated patient (name of vaccine and time/date not provided) on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)).The patient was found reactive (as expected) at 42.77 iu/ml.The quantitative result was concordant but lower than the result obtained with the diasorin trimeric method (364 bau/ml).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.Sars-cov-2 igg 1st is calibration passed on (b)(6) 2021 with reagent lot 124028 and calibrator lot 124707.System check passed on (b)(6) 2021.Qc were passing within the laboratory¿s established ranges.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.Note: medwatch number ¿2122870-2021-00144¿ has been generated to address one previous non-reactive sars-cov-2 igg (1st is) result for one vaccinated patient obtained on same analyzer on (b)(6) 2021.

Manufacturer Narrative

(b)(6).The customer did not supply patient demographics such as age, date of birth, sex, 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 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.The clinical significance of a positive or negative antibody result following covid-19 vaccination has not been established, and the results from these assays should not be interpreted as an indication or degree of protection from infection after vaccination.Per fda safety communication on 19may2021 ¿results from currently authorized sars-cov-2 antibody tests should not be used to evaluate a person¿s level of immunity or protection from covid-19 at any time, and especially after the person received a covid-19 vaccination.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.¿ 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, the diversity of antibodies, testing procedure, reagent specificity and the applied standard.Values obtained with different assay methods should not be used interchangeably.Per the who study, ¿establishment of the who international standard reference panel for anti-sars-cov-2 antibody¿, mattiuzzo et al., variability of quantitative results with the who 1st is evident manufacturer to manufacturer and method to method.Variation amongst quantitative results of serology assays are expected even when traceable to the same who international standard.Some factors which may contribute to variability of inter-manufacturer results are affinity of the antibodies in positive samples, assay format, and clinical decision points for the assay.Although variability amongst quantitative results is expected, qualitative result should be in alignment with the results of manufacturers who also have a who traceable igg assay.There is no international consensus determining the protective antibody response for sars-cov-2.In conclusion, the cause of the event cannot be determined with the available information.The access assay is not labelled for vaccine response detection.Additionally, values obtained with different assay methods should not be used interchangeably.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

Manufacturer Narrative

This event is part of field action (b)(4).

• 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
• MDR Report Key: 12460951
• MDR Text Key: 281149727
• Report Number: 2122870-2021-00145
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590746919
• UDI-Public: (01)15099590746919(17)211130(11)210602(10)124628
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: C74339
• Device Lot Number: 124628
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/26/2021
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2508-2021
• Patient Sequence Number: 1