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

Catalog Number	07028121190
Medical Device Problem Codes	Low Readings (2460); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure e402 analytical unit serial number was (b)(6).The qc trace showed cal.E alarm on 11-jan-2025 suggesting a calibration issue.The qc from 03-feb-2025 and 04-feb-2025 was consistently borderline or out of range.No qc data was provided from 05-feb-2025.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 4 patients' samples tested with elecsys vitamin b12 g2 (vitamin b12 ii) assay on a cobas pure e402 analytical unit.Sample 1: initial result: 350 pg/ml.Repeat result: 669 pg/ml.Sample 2: initial result: 100 pg/ml (accompanied by a data flag).Repeat result: 237 pg/ml.Sample 3 and sample 4 were tested on (b)(6)2025: sample 3: initial result: 214 pg/ml.Repeat result: 375 pg/ml.Sample 4: initial result: 224 pg/ml.Repeat result: 419 pg/ml.The customer had calibration and qc issues prompting the repeat of the samples in another laboratory.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The issue was detectable to the user as the qc was consistently low out of range.Based on the provided information, the root cause was consistent with an onboard stability issue of vitamin b12 ii kits on the cobas pure e402 analytical unit.A quality notification was published.

• 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: 21662738
• Report Number: 1823260-2025-00821
• Device Sequence Number: 8346891
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/09/2025

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: 04/30/2026
• Device Catalogue Number: 07028121190
• Device Lot Number: 808573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/09/2025
• 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: 73 YR
• Patient Sex: Female