ORTHO ELISA BAR CODE 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 2002-03-27 for ORTHO ELISA BAR CODE READER II 9720C01,D01,E01,F01 935240 manufactured by Internec Corporation.

Event Text Entries

[280200] The customer reported that a barcode misread occurred using the handheld intermec wand reader. Sample id 016gp00452 was read as 165000452. Log files were downloaded and it was found that the leading zero was truncated during the read process. No death or serious injury was assoicated with this incident. Please note that this complaint is beyond the 30 day reporting requirement and was found to be reportable during a complaint review.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	2250051-2002-00519
MDR Report Key	386455
Date Received	2002-03-27
Date of Report	2001-05-03
Date of Event	2001-05-03
Date Facility Aware	2001-05-03
Report Date	2002-03-27
Date Reported to Mfgr	2002-03-27
Date Added to Maude	2002-04-09
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 BAR CODE READER II
Generic Name	BAR CODE READER
Product Code	LRH
Date Received	2002-03-27
Model Number	9720C01,D01,E01,F01
Catalog Number	935240
Lot Number	NA
ID Number	NA
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	5 YR
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	375492
Manufacturer	INTERNEC CORPORATION
Manufacturer Address	80 MAIN STREET WEST ORANGE NJ 07052 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-03-27