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

Catalog Number	07027290190
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	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable folate g3 elecsys e2g result from the cobas e 801 analytical unit.The initial result was 20 ng/ml with a data flag.The automatic repeat result with a dilution was 4.68 ng/ml.The result from a second sample from the patient was 4.64 ng/ml.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number was (b)(6).Reagent issues could be excluded based on the customer's calibration and qc data.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.A general reagent problem was not present, because the qc prior to the event was within ranges.

• 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: 18182444
• Report Number: 1823260-2023-03727
• Device Sequence Number: 12684588
• Product Code: CGN
• UDI-Device Identifier: 04015630939695
• UDI-Public: 04015630939695
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• 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): 12/15/2023

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: 10/31/2024
• Device Catalogue Number: 07027290190
• Device Lot Number: 728047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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