ORTHO ELISA BARCODE READER II 9720C01, D01, E01, F01 935240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-03-12 for ORTHO ELISA BARCODE READER II 9720C01, D01, E01, F01 935240 manufactured by Ortho-clinical Diagnostics.

Event Text Entries

[271463] The customer reported that a sample barcode was misread while using the intermec wand reader. A field engineer was dispatched and system logs were analyzed. No death or serious injury was associated with this incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2250051-2002-00524
• MDR Report Key: 382395
• Date Received: 2002-03-12
• Date of Report: 2002-02-11
• Date of Event: 2002-02-11
• Date Facility Aware: 2002-02-11
• Report Date: 2002-03-11
• Date Reported to Mfgr: 2002-03-11
• Date Added to Maude: 2002-03-20
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• 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
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ORTHO ELISA BARCODE READER II
• Generic Name: BARCODE READER
• Product Code: LRH
• Date Received: 2002-03-12
• Model Number: 9720C01, D01, E01, F01
• Catalog Number: 935240
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 6 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 371450
• Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
• Manufacturer Address: 1001 US HWY 202 RARITAN NJ 088690606 US
• Baseline Brand Name: ORTHO ELISA BAR CODE READER II
• Baseline Generic Name: BAR CODE READER
• Baseline Model No: 9720C01, D01, E
• Baseline Catalog No: 935240
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-03-12