ELECSYS VITAMIN B12 II B12 G2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for ELECSYS VITAMIN B12 II B12 G2 manufactured by Roche Diagnostics.

Event Text Entries

[134463816] The investigations found a general reagent issue can be excluded. The investigation did not identify a product problem. The cause of the event could not be determined. There were no follow up/corrective actions. No devices were returned. This device is not labeled for single use and is not reprocessed or reused.
Patient Sequence No: 1, Text Type: N, H10

[134463817] This report summarizes 1 malfunction events. The customer had questionable non reproducible elecsys vitamin b12 ii results from a cobas 8000 e 602 module. The events 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2019-90003
• MDR Report Key: 8284305
• Date Received: 2019-01-29
• Date Added to Maude: 2019-01-29
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MICHAEL LESLIE
• Manufacturer Street: 9115 HAGUE ROAD NA
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer Phone: 3175214343
• Manufacturer G1: ROCHE DIAGNOSTICS GMBH
• Manufacturer Street: SANDHOFFERSTRASSE 116 NA
• Manufacturer City: MANNHEIM (BADEN-WURTTEMBERG), NA 68305
• Manufacturer Country: GM
• Manufacturer Postal Code: 68305
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ELECSYS VITAMIN B12 II
• Generic Name: RADIOASSAY, VITAMIN B12
• Product Code: CDD
• Date Received: 2019-01-29
• Model Number: B12 G2
• Lot Number: ASKU
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-29