FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 817710 · Received January 31, 2007

Report

Report Number: 2954730-2007-00056
Event Type: Malfunction
Date Received: January 31, 2007
Date of Event: January 25, 2007
Report Date: January 30, 2007
Manufacturer: HEMOSENSE, INC.
Product Code: JPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060284: FIRST TEST INR = 1.2, SECOND TEST INR = 1.9. MEAN = 1.55; SD = 0.49 %CV = 31.9%. FIRST INR = 5.8, SECOND TEST INR = 4.8, MEAN = 5.30; SD = 0.71 %CV = 13.3%. THE %CV IS GREATER THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, THE PRECISION FAILS THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED NOT PRECISE AND FURTHER TESTING IS REQUIRED AT THIS TIME. PER INTERNAL PROTOCOL, IN-HOUSE RETAIN STRIPS 060284 WERE TESTED FOR PRECISION. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE %CV IS LESS THAN OR EQUAL TO 16%, THEN IT MEETS THE CRITERIA FOR PRECISION. IF BOTH SAMPLES PASS FOR EACH LOT THEN NO FURTHER ACTION IS REQUIRED. IF ONE LOT FAILS, THEN ADDITIONAL TESTING WILL BE PERFORMED WITH 2 MORE NORMAL DONORS. IF BOTH SAMPLES FAIL ON ANY LOT OR IF ANY LOT FAILS ADDITIONAL TESTING, THEN A REVIEW OF TRENDING DATA WILL BE PERFORMED AND A COURSE OF ACTION TAKEN. RESULT OF RETAINED STRIPS TEST (LOT 060284) PERFORMED ON 11/03/06 AS FOLLOWS: LOT 060284 PT #1: NORMAL 1.1, 1.2, MEAN 1.15, SD 0.07, %CV 6.14%. PT #2: NORMAL 1.0, 1.0, 1.0, SD 0, %CV 0%. BASED ON THE ABOVE TEST RESULTS, RETAINED STRIPS LOT 060284 MEETS THE CRITERIA FOR STRIP PRECISION.

Description of Event or Problem · 1

CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: FIRST TEST INR = 1.2, SECOND TEST INR = 1.9. FIRST TEST INR = 5.8, SECOND TEST INR = 4.8.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	JPA	HEMOSENSE, INC.	*	060284

Patients

Seq	Age	Sex	Outcome	Treatment
1	*