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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-09 for * manufactured by Roche Diagnostics Corporation.

Event Text Entries

[5266010] An incorrect reagent was inadvertently loaded on one of the roche analyzers in the main chemistry lab. This was discovered 3 days later, when the qc was out during start up. All testing was immediately halted and service call was made to clean and restart w/ correct reagent.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4373517
• MDR Report Key: 4373517
• Date Received: 2014-12-09
• Date of Report: 2014-10-24
• Date of Event: 2014-09-20
• Report Date: 2014-10-24
• Date Reported to FDA: 2014-12-09
• Date Reported to Mfgr: 2014-12-31
• Date Added to Maude: 2014-12-31
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: CHEMISTRY ANALYZER.
• Product Code: JJF
• Date Received: 2014-12-09
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: 1 YR
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS CORPORATION
• Manufacturer Address: 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-12-09