MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FOLATE III; FOLIC ACID TEST SYSTEM

Catalog Number	07027290190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure instrument serial numbers were(b)(6) and (b)(6).The customer began to use reagent lot 703979 on (b)(6) 2023.On (b)(6) 2023 qc was outside of the acceptable range.The customer recalibrated but still had issues.The customer replaced the reagent pack and calibrated it.Qc was acceptable.After one week, qc was outside of the acceptable range again.Recalibrating did not resolve the issue.Monthly maintenance was performed on (b)(6) 2023.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of qc issues for elecsys folate iii (folate iii) on both of their cobas pure instruments.The customer performed a patient comparison with a different site and discrepant results were identified for 1 patient sample.It is not known if the comparison data was generated for troubleshooting purposes only or if it was used for diagnostic purposes.On (b)(6) 2023 the result from the other site using 703979 was 23 nmol/l.On (b)(6) 2023 the result using reagent lot 703979 on the customer¿s instrument was 17.5 nmol/l.On (b)(6) 2023 the result using reagent lot 728047 on the customer¿s instrument was 18.2 nmol/l.
Additional Manufacturer Narrative
The medical device problem codes were updated.The high result from the different site using reagent lot 703979 is believed to be incorrect.The customer's calibration data for reagent lot 703979 was slightly lower than expected.The customer's calibration data for reagent lot 728047 was acceptable.The sample was measured on different days at different sites.Sample stability per product labeling: "stable for 2 hours at 20-25 °c, 48 hours at 2-8 °c, 28 days at -20 °c (± 5 °c).Freeze only once.Protect from light.Store the samples at 2-8 °c if they cannot be measured immediately." based on the limited information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS FOLATE III
• Common Device Name: FOLIC ACID TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17663371
• Report Number: 1823260-2023-02846
• Device Sequence Number: 20380991
• Product Code: CGN
• UDI-Device Identifier: 04015630939695
• UDI-Public: 04015630939695
• Combination Product (Y/N): Y
• Initial Reporter Country: SW
• PMA/510(K) Number: K082340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 03/31/2024
• Device Catalogue Number: 07027290190
• Device Lot Number: 70397901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown