MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FOLATE III; ACID, FOLIC, RADIOIMMUNOASSAY

Catalog Number 07559992190

Device Problems High Test Results (2457); High Readings (2459)

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

Upon initial investigation, calibration signals were observed to be higher than expected and seem to fluctuate on both channels of the analyzer.No obvious trend is observed with calibration data.There were a few failed calibrations due to missing values or duplication error.During investigations, it was observed that quality control data was near the peer control mean.There was no obvious upward trend of controls.The investigation is ongoing.

Event Description

The initial reporter stated they have been having issues with the elecsys folate iii assay on a cobas 6000 e 601 module.The reporter stated that recovery of the assay has been unstable.Control recovery was drifting upward and they are needing to calibrate the assay often.The reporter stated the assay seems unstable on a second analyzer, but no further details were provided regarding this second analyzer.The customer provided data for two patient samples that had discrepant folate results when tested on the e 601 analyzer.The samples were repeated after a new assay calibration was performed.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The first sample initially resulted in a folate value of 26.9 nmol/l, which repeated as 20.5 nmol/l.The second sample initially resulted in a folate value of 13.7 nmol/l, which repeated as 9.2 nmol/l.The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

A reagent or instrument issue could be excluded as controls did not show any issue and the customer states the assay has been performing satisfactorily.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FOLATE III
• Type of Device: ACID, FOLIC, RADIOIMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13176099
• MDR Text Key: 290459422
• Report Number: 1823260-2022-00048
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K082340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07559992190
• Device Lot Number: 501636
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1