MAUDE Adverse Event Report: BECKMAN COULTER ACCESS SARS-COV-2 IGG II; IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number C69057

Device Problem Off-Label Use (1494)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The full identifier is (b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.Customer telephone number is (b)(6).The access sars-cov-2 igg ii assay was not returned for evaluation.There were no reports of system issues at the time of the event.No hardware errors or flags were reported in conjunction with the event.System performance indicators such as system check, calibration and quality control results were not provided for review.Two patient samples were sent to the beckman coulter complaint handling unit (chu) for investigation testing.Patient samples was tested neat with the sars-cov-2 igg ii assay.The chu obtained reactive results for both samples with the sars-cov-2 igg ii assay.The chu then tested the samples on an internal "under development" assay intended to be standardized against who standard.The assay is used for investigation purposes only.Results close to the diasorin test results were obtained.The testing demonstrated that the access and diasorin results are equivalent; no malfunction was identified with the access sars-cov-2 igg ii results.It should be noted that the access sars-cov-2 igg ii is not labeled for vaccine response detection.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On 19feb2021 the customer reported that on (b)(6) 2021, reactive covid igg ii (access sars-cov-2 igg ii, part number c69057 and lot number 922896) patient results were generated on the customer's access 2 (access 2 immunoassay analyzer, part number 81600n and serial number (b)(4)) for two patients.There was no report of injury or illness to the patients in conjunction with this event.The customer considered the reactive results too low when compared to a competitor method (diasorin sars-cov-2 igg).The two patients were vaccinated on (b)(6) 2021 and received their second doses of vaccination on (b)(6) 2021.No hardware errors or issues with other assays were reported in conjunction with this event.No hardware errors or other assay issues 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.No issues with sample integrity were reported by the customer.Sample collection, handling and processing information such as sample type, sample volume collected, sample quality, centrifugation time and speed, storage temperature and other information was not provided by the customer.

• Brand Name: ACCESS SARS-COV-2 IGG II
• 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: 11447325
• MDR Text Key: 268746491
• Report Number: 2122870-2021-00025
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590742744
• UDI-Public: (01)15099590742744(17)210531(11)201201(10)922896
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: C69057
• Device Lot Number: 922896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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