MAGNAPURE LC *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-12 for MAGNAPURE LC * manufactured by Roche Diagnostics Corporation.

Event Text Entries

[16767335] The roche magnapure is an automated system to extract purified dna from patient blood samples. The dna is then tested for genetic disorders and is also used to determine the efficacy of bone marrow transplants. It was discovered that patient samples were being co-mingled during the extraction process. This resulted in mixed dna samples and could have yielded false positive results. The contamination issue seems to only occur when using the "large volume" protocol (1. 0 ml). The lab has discontinued the large volume protocol.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 714340
• MDR Report Key: 714340
• Date Received: 2006-04-12
• Date of Report: 2006-04-12
• Date of Event: 2006-03-20
• Report Date: 2006-04-12
• Date Reported to FDA: 2006-04-12
• Date Added to Maude: 2006-05-17
• 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: MAGNAPURE LC
• Generic Name: DNA EXTRACTOR
• Product Code: LNJ
• Date Received: 2006-04-12
• Returned To Mfg: 2006-03-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 703404
• Manufacturer: ROCHE DIAGNOSTICS CORPORATION
• Manufacturer Address: 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-04-12