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	01/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 the customer reported discordant non-reactive sars-cov-2 igm (access sars-cov-2 igm assay, part number c58957, lot number 971287) results were generated for one patient 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 obtained for the patient were 0.34 s/co on (b)(6) 2021 and 0.31 s/co on (b)(6) 2021.Per customer verbal's report, the access results were discordant with reactive abbott results (abbott patient data was not provided).The patient had also non-reactive access sars-cov-2 igg results.The patient experienced flu symptoms in (b)(6) 2020.There were no pcr results available.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.Quality control (qc) was passing within the laboratory¿s established ranges.System check passed on (b)(6) 2021 and calibration passed on (b)(6) 2021 with reagent lot 971287 and calibrator lot 922426.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.
Additional Manufacturer Narrative
(b)(6).The customer did not supply patient demographics such as 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.The customer did not provide the samples or additional information for investigation.No manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.The abbott assays detect antibodies directed against the nucleocapsid of the virus while the access assays 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.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.

• 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: 11359284
• Report Number: 9680746-2021-00019
• Device Sequence Number: 2737354
• Product Code: QKO
• UDI-Device Identifier: 15099590738617
• UDI-Public: (01)15099590738617(17)210525(11)201126(10)971287
• 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): 02/22/2021

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: 05/25/2021
• Device Catalogue Number: C58957
• Device Lot Number: 971287
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR