MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS SARS-COV-2 IGG; IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number	C58961
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full identifier is case (b)(6).Age/date of birth, sex, weight and ethnicity: 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 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 passing within specifications at the time of the event.It should be noted that the access sars-cov-2 igg assay is not labeled for vaccine response detection.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2021 the customer reported that nonreactive covid igg (access sars-cov-2 igg, part number c58961 and lot number 971262) patient results were generated on the customer's dxi (dxi 800 access immunoassay analyzer, part number 973100 and serial number (b)(4)) for an undisclosed number of patients.There was no report of injury or illness to the patient in conjunction with this event.The customer considered some of the results to be discordant to a competitor method (abbott, semi-quantitative method, specific assay not provided).No specific test results were provided.The patients had been vaccinated with the sinovac chinese vaccine (vaccination dates not provided).No hardware errors or issues with other assays 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 hardware errors or issues with other assays were reported in conjunction with this 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
• Common Device Name: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• MDR Report Key: 11562672
• Report Number: 9680746-2021-00024
• Device Sequence Number: 3071926
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210724(11)201126(10)971262
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2021
• Device Catalogue Number: C58961
• Device Lot Number: 971262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1