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); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys folate iii results for 2 patient samples on a cobas e 801 analytical unit.Patient 1: the initial result was 16.80 ng/ml.The repeated result was 26.6 ng/ml the result using a new reagent (lot 827023) was 26.2 ng/ml.Patient 2: on (b)(6) 2025 the initial result was 16.10 ng/ml.The repeated result was 24.0 ng/ml.The result using a new reagent (lot 827023) was 22.9 ng/ml.The samples were repeated because the customer performed a method comparison.
Additional Manufacturer Narrative
Section b3 date of event was updated.The repeated results for patient 1 occurred on (b)(6) 2025.The result of 26.2 ng/ml was obtained with reagent (lot 775855).The initial result for patient 2 occurred on (b)(6) 2025 and the repeated results occurred on (b)(6) 2025.The result of 22.9 ng/ml was obtained with reagent (lot 775855).The expiration date for reagent lot 775855 was not provided.The calibration and qc were acceptable.A general reagent issue was excluded.The samples were frozen between measurements.The investigation did not identify a specific cause of the event.Sample-related factors could not be excluded.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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22440644
• Report Number: 1823260-2025-02084
• Device Sequence Number: 11551629
• Product Code: CGN
• UDI-Device Identifier: 04015630939695
• UDI-Public: 04015630939695
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K141426
• 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): 08/05/2025

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: 11/30/2025
• Device Catalogue Number: 07027290190
• Device Lot Number: 777398
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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 Age: 26 YR
• Patient Sex: Female