INRATIO *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-09 for INRATIO * manufactured by Hemosense, Inc..

Event Text Entries

[569413] Caller alleged imprecision with inratio. Results as follows: first test inr = 1. 7, second test inr = 1. 7; first test inr = 2. 3, second test inr = 2. 7; first test inr = 2. 4, second test inr = 2. 1, third test inr = 2. 1; first test inr = 2. 5, second test inr = 2. 4, third test inr = 2. 5.
Patient Sequence No: 1, Text Type: D, B5


[8055133] Inratio precision data provided by end-user lot_ 060600: first test inr = 1. 7, second test inr = 1. 7, mean = 1. 0; sd = 0. 00; %cv = 0. 0%. The %cv is less than or equal to 20%. Per internal procedure, tr 0150, the precision passes the criteria for precision. The test is considered precise and no further is required at this time. Inratio precision data provided by end-user lot 060600: first test inr = 2. 3, second test inr = 2. 7, mean = 2. 50; sd = 0. 28; %cv = 11. 3%. The time interval between inratio tests were done over 3 hours. Per tr0150, the comparison was invalid. No investigation required. Inratio precision data provided by end-user lot 060600: first test inr = 2. 4, second test inr = 2. 1, third test inr = 2. 1, mean = 2. 20; sd = 0. 17; %cv = 7. 9%. The %cv is less than or equal to 20%. Per internal procedure, tr 0150, the precision passes the criteria for precision. The test is considered precise and no further testing is required at this time. Inratio precision data provided be end-user lot 060600: first test inr = 2. 5, second test inr = 2. 4, third test inr = 2. 5, mean = 2. 50; sd = 0. 06; %cv = 2. 3%. The %cv is less than or equal to 20%. Per internal procedure, tr 0150, the precision passes the criteria for precision. The test is considered precise and no further testing is required at this time.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2954730-2007-00005
MDR Report Key810120
Date Received2007-01-09
Date of Report2007-01-09
Date of Event2006-12-21
Date Mfgr Received2006-12-21
Device Manufacturer Date2006-11-01
Date Added to Maude2007-01-31
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 Received2007-01-09
Model Number*
Catalog Number*
Lot Number060600
ID Number*
Device Expiration Date2008-01-31
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key797604
ManufacturerHEMOSENSE, INC.
Manufacturer Address* SAN JOSE CA 95134 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-01-09

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