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 High Test Results (2457)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 the customer reported elevated 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 access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)).On (b)(6) 2021, the initial sars-cov-2 igg (1st is) patient result was >1,914 iu/ml.Upon 1:19 manual dilution the results were >38,280 iu/ml and 32,341 iu/ml.The customer was questioning if results can be as elevated.On (b)(6) 2021, the sample was tested on an alternate dxi analyzer using the on-board dilution protocol with the access sars-cov-2 igg (1 is) assay and a similar elevated result was obtained (> 36,400 iu/ml).After 2 vaccine doses wanted to verify igg concentration before 3 vaccine dose.In review patient reported probably covid incident in (b)(6) 2021.No further information was provided regarding patient clinical file.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.Per customer verbal's report, system check passed on 06dec2021.Calibration passed on 23nov2021 with reagent lot 124756 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

The fill patient identifier is (b)(4).The customer did not supply patient demographics such as 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.Each individual immune response is unique.The sample was tested on an alternate analyzer using the on-board dilution protocol with the access sars-cov-2 igg (1 is) assay and a similar elevated result was obtained (> 36,400 iu/ml).¿the access sars-cov-2 igg (1 st is) assay exhibits total imprecision = 15.0% cv at concentrations = 30.0 iu/ml and standard deviation within = 4.50 iu/ml at concentrations < 30.0 iu/ml shown in the tables below.¿ the dilution was performed manually.Local support reviewed dilution process with the customer.In conclusion, the elevated results are likely correct.The cause of the discrepant diluted results cannot be determined.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: 13024280
• MDR Text Key: 287607178
• Report Number: 2122870-2021-00183
• 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: PL
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• 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: 12/08/2021
• Date Manufacturer Received: 12/08/2021
• 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 Age: 85 YR
• Patient Sex: Male