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	False Negative Result (1225)
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
(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 reagent was not returned for evaluation.No hardware errors or other assay issues were reported in conjunction with this event.¿ 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.The euroimmun sars-cov-2 elisa (igg) also targets the spike protein.¿ no manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.In conclusion the cause of this event is unknown.There is malfunction as original result is discordant with 2 or more replicate measurements of the same specimen on other devices.
Event or Problem Description
On (b)(6) 2021 the customer reported discordant non-reactive sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 971262) results were generated for several vaccinated patients on the customer's unicel dxi 600 access immunoassay analyzer (part number a30260 and serial number (b)(4)).The customer reported non-reactive sars-cov-2 igg patient results for several vaccinated patients (number of patients was not specified) discordant to results obtained with immunofluorescence and elisa euroimmun sars-cov-2 igg methods (no data and no time of analysis were reported).Reactive results were expected.The patients were vaccinated with the sinovac vaccine.The customer provided an example for one patient sample (no occurrence date was provided): the access sars-cov-2 igg result was 0.27 s/co, the immunofluorescence method result was 17 (cut-off unknown, reactive status) and the elisa euroimmun sars-cov-2 igg result was 37 (cut-off 1.1, reactive status).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 21jan2021 with reagent lot 971262 and calibrator lot 988708.Quality control (qc) was passing within the laboratory¿s established ranges.There were no issues with sample integrity reported by the customer.Sample collection, handling and processing information such as sample type, sample volume collected, centrifugation, storage and other sample related 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: 11539928
• Report Number: 9680746-2021-00023
• Device Sequence Number: 19790601
• 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): 03/22/2021

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
• Distributor Facility Aware Date: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1