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 Erratic Results (4059)

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

Event Date 02/04/2021

Event Type  malfunction  

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 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.A preventive maintenance was performed on 17feb2021.No hardware issue was reported.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 non-repeatable sars-cov-2 igm patient results (access sars-cov-2 igm assay, part number c58957, lot number was not supplied) were generated on the customer's unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(4)).On (b)(6) 2021, the sars-cov-2 igm initial result was 0.52 s/co (non-reactive).Upon repeat the same day, the result was 3.39 s/co (reactive).It is unknown if the customer expected the result to be reactive or non-reactive.Per customer¿s verbal report, when they have this type of discordant data they don¿t report the result but send the sample in service so they no longer mange it.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.Per customer¿s verbal report, system checks have been passing and quality control (qc) was within the laboratory¿s established ranges.No hardware errors or other assay issues were reported in conjunction with this event.A preventive maintenance was performed on 17feb2021.No hardware issue was reported.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
• MDR Report Key: 11884111
• MDR Text Key: 281513993
• Report Number: 9680746-2021-00040
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• 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
• Distributor Facility Aware Date: 02/05/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1