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	12/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The vitamin b12 ii reagent expiration date was not provided.The cobas pure sample supply unit serial number was (b)(4).Qc was within the ranges.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum/plasma sample tested with elecsys vitamin b12 g2 (vitamin b12 ii) assay on a cobas pure sample supply unit.Initial result: 107 pg/ml.No questionable result was reported outside the laboratory as the customer noticed that the result did not match the patient's previous results.The sample was then repeated.Repeat result: 318 pg/ml.
Additional Manufacturer Narrative
Section d4 was updated.Correction: from cobas pure sample supply unit to cobas e402 immunoassay analyzer.The sample was tested on a cobas e402 serial number (b)(6).The calibration was last performed 11 weeks before the day of the event and it was acceptable.The alarm trace and the pre-analytical data did not show any abnormality.A general reagent problem can be excluded because the qc prior to the event was within range.The cause of the event could not be determined.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18537914
• Report Number: 1823260-2024-00173
• Device Sequence Number: 15342838
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• PMA/510(K) Number: K060755
• 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): 02/16/2024

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: 04/30/2025
• Device Catalogue Number: 07028121190
• Device Lot Number: 740845
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 02/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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