MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN D TOTAL III; VITAMIN D TEST SYSTEM

Catalog Number	09038086190
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	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys vitamin d total iii results for 1 patient sample on a cobas e 801 analytical unit.The initial result was >120 ng/ml.On (b)(6) 2026, the sample was repeated on another module, and the result was 31.1 ng/ml.On (b)(6) 2026, the sample was repeated on the same module as the initial result, and the result was 31.1 ng/ml.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The qc was acceptable.A general reagent issue was excluded.The alarm trace showed numerous sample quality alarms on the date of the event.The investigation reviewed images provided by the customer.The sample showed no bubbles, foam, or fibrin.The images showed that the instrument's surface is dirty and requires cleaning.The investigation did not identify a specific cause of the event.The investigation did not identify a product problem.

• Brand Name: ELECSYS VITAMIN D TOTAL III
• Common Device Name: VITAMIN D 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: 24689355
• Report Number: 1823260-2026-01077
• Device Sequence Number: 10041972
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K210901
• 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): 04/22/2026

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: 08/31/2026
• Device Catalogue Number: 09038086190
• Device Lot Number: 86897201
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/22/2026
• 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