MAUDE Adverse Event Report: Roche Diagnostics Elecsys Vitamin B12 II; radioassay, vitamin b12

Catalog Number	07028121190
Medical Device Problem Codes	High Test Results (2457); High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys vitamin b12 ii assay on a cobas 8000 e 801 module.Initial result: 756.No questionable result was reported outside the laboratory, and the sample was repeated on a different module.Repeat result: 364.The unit of measurement was not provided.
Additional Manufacturer Narrative
The cobas 8000 e 801 module serial number was (b)(6).The alarm trace showed multiple sample clot alarms.The customer performed an air purge, liquid flow cleaning, and qc, and they were within specifications.The instrument was performing within specifications.No further issues were reported after the intervention.The instrument maintenance steps resolved the issue.The cause of the event could not be determined, but it was consistent with either an instrument issue requiring maintenance or sample interference (hyperproteinemia causing protein gel formation in assay cups).

• Brand Name: Elecsys Vitamin B12 II
• Common Device Name: radioassay, vitamin b12
• Manufacturer (Section D): Roche Diagnostics; 9115 hague road; indianapolis IN 46250 -045
• 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: 50792414
• Report Number: 1823260-2026-03787
• Device Sequence Number: 9415584
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K151786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 07028121190
• Device Lot Number: 95413501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/16/2026
• 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