HEMOCHRON JR PT CUVETTE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-05 for HEMOCHRON JR PT CUVETTE * manufactured by Itc, Inc.

Event Text Entries

[19929422] The itc (international technidyne corporation) cuvette was used for point of care testing inr (international normal ratio). The lot used on the day of the event may have reported higher than actual patient results. The cuvette was recalled by itc. The patient in question was admitted with cva before the recall. ======================manufacturer response for hemochron jr. Pt cuvette j201, hemochron jr pt cuvette (per site reporter)======================this was in response to a voluntary recall by the manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2211336
• MDR Report Key: 2211336
• Date Received: 2011-08-05
• Date of Report: 2011-08-05
• Date of Event: 2011-05-02
• Report Date: 2011-08-05
• Date Reported to FDA: 2011-08-05
• Date Added to Maude: 2011-08-15
• 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: HEMOCHRON JR PT CUVETTE
• Generic Name: HEMOCHRON JR. PT CUVETTE J201
• Product Code: GFO
• Date Received: 2011-08-05
• Returned To Mfg: 2011-05-17
• Model Number: *
• Catalog Number: *
• Lot Number: M0JPT079
• ID Number: *
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ITC, INC
• Manufacturer Address: 6-8 OLSEN AVE. EDISON NJ 08820 US 08820

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2011-08-05