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

Model Number B12 G2

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys vitamin b12 ii assay on a cobas e 411 analyzer (serial number unknown) and compared to a competitor method.The sample initially resulted in a vitamin b 12 ii value of 640 pg/ml on the cobas e 411 analyzer.The reporter mentioned that this result was reproducible.No specific value was provided.The sample was repeated with a competitor method, resulting in a vitamin b 12 value of 468 pg/ml.It was asked but it is unknown which result is considered to be correct.No questionable result was reported outside of the laboratory.

Manufacturer Narrative

Calibration results from 26-jan-2023 were below the expected range for both calibrator levels.Quality control results were within the expected range.There is no indication for a reagent issue.The last instrument maintenance was performed at the beginning of january-2023.The patient¿s sample was requested but not available for investigation.Both roche and competitor-generated results match in the relation to the respective expected ranges.The measured vitamin b 12 value of a patient¿s sample can vary depending on the testing procedure used.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods, and the standardization methodology used.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16440916
• MDR Text Key: 310334799
• Report Number: 1823260-2023-00588
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K060755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: B12 G2
• Device Catalogue Number: 07212771190
• Device Lot Number: 66190705
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1