INRATIO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-04-26 for INRATIO * manufactured by Hemosense, Inc..

Event Text Entries

[448057] The caller alleged discrepant results when compared with the lab. Results reported as follows: inratio pt#1 6. 9 24 hours later, lab 2. 0. Pt#2 inratio 4. 0 24 hours later, lab 2. 0
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2954730-2006-00226
MDR Report Key706506
Report Source04
Date Received2006-04-26
Date of Report2006-04-21
Date of Event2006-04-19
Date Mfgr Received2006-04-19
Date Added to Maude2006-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street651 RIVER OAKS PARKWAY
Manufacturer CitySAN JOSE CA 95134
Manufacturer CountryUS
Manufacturer Postal95134
Manufacturer Phone4082403800
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINRATIO
Generic NamePROTHROMBIN TIME TEST
Product CodeGIS
Date Received2006-04-26
Model Number*
Catalog Number*
Lot NumberNI
ID Number*
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key695571
ManufacturerHEMOSENSE, INC.
Manufacturer Address* SAN JOSE CA 95134 US


Patients

Patient NumberTreatmentOutcomeDate
10 2006-04-26

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