INRATIO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-03 for INRATIO * manufactured by Hemosense, Inc..

Event Text Entries

[515967] Caller alleded a patient was hospitalized due to the inr results. Inratio and lab results were unavailable.
Patient Sequence No: 1, Text Type: D, B5

[7791654] Caller didn't provide actual meter and lab results. Insufficient complaint information. Products will be investigated when returned.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 2954730-2006-00430
• MDR Report Key: 745169
• Date Received: 2006-08-03
• Date of Report: 2006-07-31
• Date of Event: 2006-07-31
• Date Mfgr Received: 2006-07-31
• Device Manufacturer Date: 2005-10-01
• Date Added to Maude: 2006-08-09
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 651 RIVER OAKS PARKWAY
• Manufacturer City: SAN JOSE CA 95134
• Manufacturer Country: US
• Manufacturer Postal: 95134
• Manufacturer Phone: 4082403800
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INRATIO
• Generic Name: PROTHROMBIN TIME TEST
• Product Code: GIS
• Date Received: 2006-08-03
• Model Number: *
• Catalog Number: *
• Lot Number: 050678
• ID Number: *
• Device Expiration Date: 2007-01-31
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 732955
• Manufacturer: HEMOSENSE, INC.
• Manufacturer Address: * SAN JOSE CA 95134 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2006-08-03