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	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a sample mismatch while using the cobas pro ssu analyzer.The customer manually programmed a sample for sodium and serum indices using the patient's name as the sample id (b)(6).However, when the sample was loaded on the analyzer, it populated a different patient name and a vitamin b12 test was added.When the rack was loaded, the system registered the sample with a previous patient's sample id, (b)(6).The result for vitamin b12 was 1376 pg/ml.Multiple other patient samples were manually programmed, and those all ran appropriately.The suspect sample was then manually reprogrammed in the same manner, except it was programmed to run in a different position on the same rack (rack s40012-4).The sample then ran correctly.The result for vitamin b12 was 325 pg/ml.No results were released outside of the laboratory.
Additional Manufacturer Narrative
The cobas pro ssu serial number was (b)(6).The field service engineer could not determine a cause and was unable to reproduce the issue.He and the customer manually programmed samples without issues.The customer stated that there was a possibility that the event was due to user error.The investigation is ongoing.
Additional Manufacturer Narrative
A general reagent or analyzer problem was not present because the qc was within range before the sample measurement.No relevant alarms were present in the analyzer alarm trace.The investigation was unable to determine a specific root cause.There was no product problem identified.

• 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: 24628275
• Report Number: 1823260-2026-00980
• Device Sequence Number: 15699665
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 04/30/2026
• Device Catalogue Number: 07028121190
• Device Lot Number: 80857301
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/17/2026
• 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 Age: 61 YR
• Patient Sex: Female