FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 871560 · Received September 22, 2006

Report

Report Number: 2954730-2006-00513
Event Type: Malfunction
Date Received: September 22, 2006
Date of Event: September 20, 2006
Report Date: September 20, 2006
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 060019: 09/2006; FIRST TEST INR=>7.5, SECOND TEST INR=3.6, MEAN=NA, SD=NA; % CV=NA. THE % CV CANNOT BE DETERMINED. PRODUCTS WILL BE TESTED. PER INTERNAL PROCEDURE, IN-HOUSE RETAIN STRIPS 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 RETRAINED STRIPS TEST (LOT 060019) PERFORMED APPROX THREE MONTHS EARLIER AS FOLLOWS: RESULT OF RETRAINED STRIPS TEST (LOT 060019) PERFORMED ON THE SAME DAY AS FOLLOWS: LOT 060019 PT #1 NORMAL =1.0, NORMAL=1.1, MEAN=1.05, SD=0.07, %CV= 6.7%; PT #2 : NORMAL=0.8, NORMAL=0.9, MEAN=0.85, SD=0.07, %CV= 8.31%. BASED ON THE ABOVE TEST RESULTS, RETAINED STRIPS LOT 060019 MEETS THE CRITERIA FOR STRIP PRECISION.

Description of Event or Problem · 1

CALLER ALLEGED IMPRECISION WITH INRATIO. RESULTS AS FOLLOWS: 09/2006; FIRST TEST INR= >7.5, SECOND TEST INR= 3.6. CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:DATE: THE SAME DAY; INRATIO:3.6; LAB:10.4.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	JPA	HEMOSENSE, INC.	*	060019

Patients

Seq	Age	Sex	Outcome	Treatment
1	*