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

Catalog Number	07028121190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Chemical Problem (2893); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys vitamin b12 ii results from the cobas e 801 analytical unit.The initial results are below 100 pg/ml.Upon repeating the samples on another e801 analyzer, the results are not below 100 pg/ml.One result was 427 pg/ml, the other results are between 200 pg/ml and 300 pg/ml.
Additional Manufacturer Narrative
The cobas e 801 analytical unit serial number is (b)(6).The customer replaced the reagent with a new one from the same lot.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and qc data was not provided.Global recovery of the reagent lot 832087 with the newest lots was analyzed.The global recovery was inconspicuous, consistent with the possibility that the issue is local.The alarm trace report showed several hardware-related warnings, as well as several alarms for sample clots.The issue was resolved locally with fresh reagent kits with different reagent lot numbers.The new lot number was not provided.The root cause could be consistent with a single kit failure.The investigation was unable to determine a direct root cause.

• 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: 22113586
• Report Number: 1823260-2025-01667
• Device Sequence Number: 12552014
• Product Code: CDD
• UDI-Device Identifier: 04015630939848
• UDI-Public: 04015630939848
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 06/25/2025

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: 832087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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