FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 1130007 · Received August 19, 2008

Report

Report Number: 2954730-2008-00503
Event Type: Malfunction
Date Received: August 19, 2008
Date of Event: July 22, 2008
Report Date: August 13, 2008
Manufacturer: HEMOSENSE, INC.
Product Code: JPA
Removal / Correction Number: NI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO REPEATED TEST PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 6; INRATIO: 1; AVERAGE: 3.5; SD: 3.54 % CV: 101.02. THE %CV IS GREATER THAN 20% AND CRITERIA IS NOT MET AS PER INTERNAL PROCEDURE TR#0150 (REV 2) SO FUNCTIONAL TESTING WILL BE PERFORMED AS PART OF THE COMPLAINT INVESTIGATION. END USER ALSO PROVIDED THE LAB TEST RESULTS WHICH WAS DONE ONE DAY LATER. RESULT#: 1, INRATIO: 6, LAB 1, MEAN: 3.5, CONFIDENT LIMITS: 2.0-5.0. RESULT#: 2, INRATIO: 1; LAB 1, MEAN: 1, CONFIDENT LIMITS: 0.8-1.2. THE MEAN FOR RESULT #1 IS NOT WITHIN CONFIDENT LIMITS AS PER INTERNAL PROCEDURE. THE MEAN FOR RESULT #2 IS WITHIN CONFIDENT LIMITS AS PER INTERNAL PROCEDURE. THE PRODUCT WILL BE INVESTIGATED. THE END USER PROVIDED A LAB TEST RESULT WHICH WAS DONE ONE DAY LATER. AS PER INTERNAL PROCEDURE, IF THE TIME ELAPSED EXCEEDS THREE HOURS, THERE IS A HIGH POSSIBILITY THAT THE DISCREPANCIES ARE DUE TO CHANGE IN STATUS OF THE PATIENT.

Description of Event or Problem · 1

THE CALLER ALLEGED DISCREPANT RESULTS WHEN REPEATED TEST WITH INRATIO; THE RESULTS ARE AS FOLLOWS: INRATIO 6; INRATIO 1. THE CALLER ALSO PROVIDED THE LAB RESULTS WHICH WAS DONE ONE DAY LATER THAN THE REPEATED TEST. THE LAB TEST RESULTS ARE AS FOLLOWS: LAB RESULT 1.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	JPA	HEMOSENSE, INC.	0100004	NP

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI