ELECSYS 2010 ANALYZER * 1568248

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2001-01-19 for ELECSYS 2010 ANALYZER * 1568248 manufactured by Roche Diagnostics.

Event Text Entries

[139506] Some analyzer pipette tips have the tips blocked and may produce inaccurate results.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2001-00009
• MDR Report Key: 313333
• Report Source: 07
• Date Received: 2001-01-19
• Date of Report: 2001-01-15
• Date Added to Maude: 2001-01-25
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DEBARA REEK
• Manufacturer Street: 9115 HAGUE RD.
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer Phone: 3175763857
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: NO
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ELECSYS 2010 ANALYZER
• Generic Name: IMMUNOASSAY ANALYZER
• Product Code: LCI
• Date Received: 2001-01-19
• Model Number: *
• Catalog Number: 1568248
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: NA
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 303070
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US
• Baseline Brand Name: ELECSYS 2010 ANALYZER
• Baseline Generic Name: IMMUNOASSAY ANALYZER
• Baseline Model No: *
• Baseline Catalog No: 1568248
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-01-19