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

Catalog Number	C58957
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fill patient identifier is case-(b)(6).The number of patients involved is unknown.The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sars-cov-2 igm reagent was not returned for evaluation.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 did not demonstrate an issue with the system.The customer did not provide the samples or additional information for investigation.Sars-cov-2 is an enveloped non-segmented positive-sense rna virus.It has several structural proteins including spike (s), envelope (e), membrane (m) and nucleocapsid (n).The spike protein (s) contains a receptor binding domain (rbd) which is responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ace2).It is found that the rbd of the sars-cov-2 s protein strongly interacts with the human ace2 receptor leading to endocytosis into the host cells and viral replication.The access assay detect antibodies directed against the spike protein, which are more likely to neutralize the virus.Some patient may develop antibodies directed only against the nucleoproteins and not against the spike protein and vice versa, which may explain some differences in results.The local support organization explained differences between assays targeting nucleoprotein and assays targeting spike protein.In conclusion, the cause of this event cannot be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
Event or Problem Description
On (b)(6) 2021 the customer reported discordant non-reactive sars-cov-2 igm (access sars-cov-2 igg assay, part number c58957, lot number 971256) results were generated for several patients on the customer's unicel dxi 800 access immuno analyzer (part number 973100 and serial number (b)(4)).The access sars-cov-2 igm results were discordant with alternate methods, alternate methods used are unknown.The results obtained by the customer were not provided and the number of patients is unknown.No affect to patients or end-users has been reported in connection with this event.No hardware errors or issues with other assays were reported in conjunction with this event.Calibration passed on (b)(6) 2020 with reagent lot 971256 and calibrator lot 922426.Quality control (qc) was passing within the laboratory¿s established ranges.System check passed on (b)(6) 2021.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: the customer reported discordant non-reactive sars-cov-2 igm results on a second dxi analyzer serial number 606436.Another report was filed related to this instrument.

• Brand Name: ACCESS SARS-COV-2 IGM
• 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: 11285415
• Report Number: 9680746-2021-00015
• Device Sequence Number: 17104452
• Product Code: QKO
• UDI-Device Identifier: 15099590738617
• UDI-Public: (01)15099590738617(17)210410(11)201012(10)971256
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/05/2021

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: 04/10/2021
• Device Catalogue Number: C58957
• Device Lot Number: 971256
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1