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

Model Number	E801
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	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys vitamin b12 on a cobas e 801 analytical unit.The sample initially resulted in a vitamin b12 value of < 150 pg/ml.The value was questioned by the doctor since it did not match the patient's history.The sample was repeated on a siemens analyzer, resulting in a vitamin b12 value of 427 pg/ml.The repeat value was deemed correct.A second sample collected from the patient resulted in a vitamin b12 value of 293 pg/ml.
Additional Manufacturer Narrative
The vitamin b12 reagent lot number was 832087.The reagent expiration date was requested, but not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and controls were acceptable.A general reagent issue can be ruled out.Isolated non-reproducible results do not represent a general malfunction of the assay a review of alarm trace data showed 12 sample foam detection and sample short alarms.These alarms indicate issues with sample quality.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch fields d1, d2, d4, g1, and g4 have been updated.

• 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 46250-0457
• MDR Report Key: 22467549
• Report Number: 1823260-2025-02099
• Device Sequence Number: 7904769
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/15/2025

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 Expiration Date: 07/31/2026
• Device Model Number: E801
• Device Catalogue Number: 07028121190
• Device Lot Number: 832087
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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 Age: 58 YR
• Patient Sex: Female