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 Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fill patient identifier is case-(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, flags or other assay issues were reported in conjunction with this event.Service was dispatched.Field service engineer (fse) verified calibration, controls, system check and pipetting.No hardware malfunction was observed.The customer was advised to make sure their pre-analytical sample handling process is correctly followed.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 one non-reproducible reactive sars-cov-2 igm (access sars-cov-2 igm assay, part number c58957, lot number 971287) result was generated on the customer's unicel dxi 800 access immuno analyzer (part number 973100 and serial number (b)(4)).The access result of 11.49 s/co (reportable range: reactive =1.0 s/co) was obtained on (b)(6) 2021.Upon repeat the following day, a result at 0.14 s/co was obtained on same analyzer and a result at 0.18 s/co was obtained on instrument serial number (b)(4).The sample was repeated again on (b)(6) 2021 on initial instrument with a result at 0.17 s/co.The sars-cov-2 igg result is non-reactive and is not questioned.No affect to patients or end-users has been reported in connection with this event.The customer did not indicate whether the result was reported out of the laboratory.No hardware errors or issues with other assays were reported in conjunction with this event.Calibration passed on (b)(6) 2021 with reagent lot 971287 and calibrator lot 922427.Quality control (qc) was passing within the laboratory¿s established ranges.Carryover test passed on (b)(6) 2021.System check passed on (b)(6) 2021.Service was dispatched.Field service engineer (fse) verified calibration, controls, system check and pipetting.No hardware malfunction was observed.The customer was advised to make sure their pre-analytical sample handling process is correctly followed.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 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: 11328043
• Report Number: 9680746-2021-00018
• Device Sequence Number: 1045971
• 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): 02/15/2021

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?: Yes
• 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: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR