MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS VITAMIN B12 II; RADIOASSAY, VITAMIN B12

Catalog Number	07028121190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys vitamin b12 ii (b12 ii) on a cobas e 801 analytical unit.The initial result was < 100 pg/ml with a data flag.On (b)(6) 2025, the physician questioned the initial result, and the sample was repeated with a result of 402 pg/ml.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).Calibration and qc were acceptable.No issues were noted with the sample volume.No alarms were observed aside from
Additional Manufacturer Narrative
The customer has not complained of any further issues.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS VITAMIN B12 II
• Common Device Name: RADIOASSAY, VITAMIN B12
• 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: 22751459
• Report Number: 1823260-2025-02422
• Device Sequence Number: 15793685
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K151786
• 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): 09/24/2025

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: 85339401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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