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	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The number of questioned patient samples was not provided.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."aspiration monitor detected possible obstruction" errors occurred just before the event.Although there were no issues with sample integrity reported by the customer, this error may occasionally occur with samples with clots and fibrins.A beckman coulter field service engineer (fse) was dispatched to the customer site to assess the customers instrument.The processes, calibration, controls, system check and dtest were analyzed, all of which are within the quality specifications.It was not possible to analyze and repeat samples in the pack in question because it was used until the end.In conclusion, although a preanalytical issue is suspected, it could not be verified as the customer did not report any specific issue related to sample handling.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.The cause of this event cannot be determined with the available information.
Event or Problem Description
On 18mar2021 the customer reported false reactive sars-cov-2 igm (access sars-cov-2 igm assay, part number c58957, lot number 971287) results were generated on the customer's unicel dxi 800 access immuno analyzer (part number 973100 and serial number (b)(4)).Customer reported results outside of the laboratory and results were questioned.When the customer repeated the samples on dxi 800 serial number (b)(4), the results were non-reactive.The exact number of patients results questioned was not provided.No affect to patients or end-users has been reported in connection with this event.Calibration passed on 18feb2021 with reagent lot 971287 and calibrator lot 922427.Quality control (qc) was passing within the laboratorys established ranges at the time of the event.System check passed on 15mar2021.On 17mar2021 from 12:43 am to 01:16 am, four (4) "aspiration monitor detected possible obstruction" errors occurred just before the event.Although there were no issues with sample integrity reported by the customer, this error may occasionally occur with samples with clots and fibrins.A beckman coulter field service engineer (fse) was dispatched to the customer site on 24march2021 to assess the customers instrument.The processes, calibration, controls, system check and dtest were analyzed, all of which are within the quality specifications.It was not possible to analyze and repeat samples in the pack in question because it was used until the end.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: 11626418
• Report Number: 9680746-2021-00031
• Device Sequence Number: 11649241
• 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): 04/07/2021

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: 03/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1