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

Catalog Number C58957

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

The fill patient identifier is (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 igm reagent was not returned for evaluation.There were no reports of other instrument issues.There were no reports of other issues with this assay.Arcdata analysis for the csv data file provided did not highlight a performance issue.Cex, pex and lex flags were observed meaning that calibration was expired, open pack stability time had elapsed for the reagent pack and the reagent lot was expired.The customer was recommended to clean the instrument.A normal preventive maintenance (pm) was scheduled for the instrument.During this pm, the customer checked the instrument technical state and no issue was detected.The customer was retrained on how to perform maintenance.Although a use error is suspected as the customer may not clean the aspirate probes properly and is using expired material, 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.Note: no udi and no manufactured date could be provided as no lot number was supplied.

Event Description

On (b)(6) 2021 the customer reported one non-repeatable erroneously elevated sars-cov-2 igm patient result (access sars-cov-2 igm assay, part number c58957, lot number was not supplied) was generated on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)).On (b)(6) 2021, the sars-cov-2 igm initial result was 1.67 s/co (reactive).Upon repeat twice the results were 0.16 s/co (non-reactive).No further information was provided.No information regarding patient clinical file was provided (pcr, symptoms or vaccination information not provided).No affect to patients or end-users has been reported in connection with this event.No hardware errors or other assay issues were reported in conjunction with this event.Calibration passed on 31aug2021 with reagent lot 172053 and calibrator lot 922828.Arcdata analysis for the csv data file provided did not highlight a performance issue.Cex, pex and lex flags were observed meaning that calibration was expired, open pack stability time had elapsed for the reagent pack and the reagent lot was expired.The customer was recommended to clean the instrument.A normal preventive maintenance (pm) was scheduled for the instrument.During this pm, the customer checked the instrument technical state and no issue was detected.No issues with sample integrity were 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
• Type of Device: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12575994
• MDR Text Key: 274753677
• Report Number: 2122870-2021-00159
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: LO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C58957
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/22/2021
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2000
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1