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

Model Number B12 G2

Device Problem Low Test Results (2458)

Patient Problem Test Result (2695)

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.The follow up action for the event was that the reagent kit was replaced.Afterwards, the issue was resolved.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.

Event Description

This report summarizes malfunction event.Low results were generated by the elecsys vitamin b12 immunoassay on a cobas e 411 immunoassay analyzer.The event involved a total of 1 patient.The patient's age was requested but was not provided.The patient's weight was requested but was not provided.The patient's gender was requested but was not provided.The patient's race was requested but was not provided.The patient's ethnicity was requested but was not provided.

• Brand Name: ELECSYS VITAMIN B12 II
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis, in
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg), 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; indianapolis, in
• MDR Report Key: 9986270
• MDR Text Key: 198733373
• Report Number: 1823260-2020-90041
• Device Sequence Number: 1
• Product Code: CDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Device Model Number: B12 G2
• Device Lot Number: 39666302
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2020
• Type of Device Usage: N
• Patient Sequence Number: 1