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

Catalog Number	09038086190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
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 with a data flag.This result was considered falsely high.The repeated result was 31 ng/ml.The sample was repeated because the initial result didn't match the patient's clinical history.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The field service representative cleaned the sample and reagent probes, performed a system air purge, and performed checks.The investigation is ongoing.
Additional Manufacturer Narrative
The checks performed by the field service representative passed.The investigation did not identify a product problem.The investigation determined the issue was consistent with pre-analytical handling issues.

• 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: 24082476
• Report Number: 1823260-2026-00186
• Device Sequence Number: 9783939
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 02/09/2026

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: 09/30/2026
• Device Catalogue Number: 09038086190
• Device Lot Number: 88165901
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/09/2026
• 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