MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FOLATE GEN 3; FOLIC ACID TEST SYSTEM

Model Number	FOLATE G3
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys folate iii assay results from cobas e 801 analytical unit serial number (b)(4).The initial results were >20 ng/ml and >20 ng/ml.The repeat results with a 1:2 dilution by the instrument were 8.08 ng/ml and 7.17 ng/ml.The repeat result with a 1:3 dilution was 7.38 ng/ml.The repeat result with a 1:4 dilution was 3.85 ng/ml.The repeat results with a 1:5 dilution by the instrument were 3.0 ng/ml and <6.00 ng/ml.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The sample was submitted for investigation and was tested on a cobas e801 analyzer with reagent lot 529809.The results undiluted were 6.75 ng/ml and 7.12 ng/ml.The results with a 1:2 dilution were 5.95 ng/ml and 5.67 ng/ml.The results with a 1:5 dilution were 3.61 ng/ml and 3.13 ng/ml.The results with a 1:10 dilution were <6.00 ng/ml and <6.00 ng/ml.Per product labeling for the assay, the recommended dilution is 1:2 (either automatically by the analyzer or manually) and the concentration of the diluted sample must be = 8.5 ng/ml or = 19.3 nmol/l.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FOLATE GEN 3
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12821600
• Report Number: 1823260-2021-03388
• Device Sequence Number: 11988376
• Product Code: CGN
• UDI-Device Identifier: 04015630939695
• UDI-Public: 04015630939695
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/14/2021

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: 11/30/2022
• Device Model Number: FOLATE G3
• Device Catalogue Number: 07027290190
• Device Lot Number: 53060901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMINOLEBAN EN; BENZBROMARONE; FUROSEMIDE; ISOSORBIDE DINITRATE; LANSOPRAZOLE; SODIUM FERROUS CITRATE; URSODEOXYCHOLIC ACID
• Patient Sex: Unknown