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	01/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure e 402 analytical unit serial number was (b)(6).The calibration and qc were acceptable.No relevant alarms occurred.The customer and service maintenance were completed per the specifications.The instrument surfaces were adequately clean.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 7 patients' samples tested with elecsys vitamin d total iii assay on a cobas pure e 402 analytical unit.Sample 1: initial result: 117 ng/ml.1st repeat result: 22 ng/ml.2nd repeat result: 24 ng/ml (tested with the new reagent pack).Sample 2: initial result: 82.8 ng/ml.1st repeat result: 31.7 ng/ml.2nd repeat result: 34.72 ng/ml (tested with the new reagent pack).Sample 3: initial result: >120 ng/ml.1st repeat result: 46.3 ng/ml.2nd repeat result: 49.44 ng/ml (tested with the new reagent pack).Sample 4: initial result: 78.6 ng/ml.Repeat result: 23.7 ng/ml (tested with the new reagent pack).Sample 5: initial result: 93.1 ng/ml.Repeat result: 30.9 ng/ml (tested with the new reagent pack).Sample 6: initial result: 62.4 ng/ml.Repeat result: 28.3 ng/ml (tested with the new reagent pack).On (b)(6) 2026: sample 7: initial result: >120 ng/ml.Repeat result: 50.4 ng/ml.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The customer used a centrifugation time of 5 minutes at 1849 g.Based on the type of sample tubes used, the centrifugation time should be 10 minutes at 1300-2000 g or 5 minutes at 3000 g.The investigation determined the event was due to preanalytical 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: 24459975
• Report Number: 1823260-2026-00719
• Device Sequence Number: 9621035
• Product Code: MRG
• UDI-Device Identifier: 07613336172650
• UDI-Public: 07613336172650
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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): 03/30/2026

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: 868972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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