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 08/30/2021

Event Type  malfunction  

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.There have not been any studies yet comparing the access sars-cov-2-igg (1 st is) assay to any other manufacturers.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.Results obtained with the access assay may not be used interchangeably with values obtained with different manufacturers¿ test methods.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 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 generated reactive results, concordant with other manufacturers qualitative results.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.Differences between manufacturers are expected.

Event Description

On (b)(6) 2021 the customer reported one 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 on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)).On (b)(6) 2021 the initial low reactive sars-cov-2 igg 1st is patient result was 33.1 iu/ml for a cut-off at 30 iu/ml.The result was concordant but lower than the result obtained with the diasorin trimeric method (176 bau/ml for a cut-off at 33.8 bau/ml).This patient was vaccinated on (b)(6) 2021.No further information was provided.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 124628 and calibrator lot 124707.Quality control (qc) was 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.

Manufacturer Narrative

This event is part of field action fa-21047.

• 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: 12480424
• MDR Text Key: 281017766
• Report Number: 2122870-2021-00151
• 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: 09/16/2021
• 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: 09/04/2021
• 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