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	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the e 801 analyzer was (b)(6).The investigation is ongoing.Medwatch field e1 initial reporter establishment name - the full facility name was provided as "(b)(6)".
Event or Problem Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested with elecsys vitamin d total iii on a cobas e 801 analytical unit.All patient samples initially recovered values around 100 ng/ml.When the reagent pack was exhausted, a new reagent pack was placed into use.The patient samples were repeated using the new reagent pack and discrepancies were observed.The customer provided examples of four patient samples with discrepant vitamin d results.The first sample initially resulted in a vitamin d value of 101 ng/ml and it repeated as 9.31 ng/ml.The second sample initially resulted in a vitamin d value of 91.4 ng/ml and it repeated as 9.96 ng/ml.The third sample initially resulted in a vitamin d value of 113 ng/ml and it repeated as 59.4 ng/ml.The fourth sample initially resulted in a vitamin d value of 102 ng/ml and it repeated as 17.7 ng/ml.
Additional Manufacturer Narrative
Quality controls were within range prior to the event.A review of alarm trace data showed no relevant alarms.The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• 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: 24243955
• Report Number: 1823260-2026-00358
• Device Sequence Number: 9592899
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/18/2026

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 Catalogue Number: 09038086190
• Device Lot Number: 91126501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 05/18/2026
• 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