FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 915881 · Received February 20, 2007

Report

Report Number: 2954730-2007-00086
Event Type: Malfunction
Date Received: February 20, 2007
Date of Event: February 7, 2007
Report Date: February 19, 2007
Manufacturer: HEMOSENSE, INC.
Product Code: JPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

DESCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: IN 2007; INRATIO: 1.6; LAB: 6.0; MEAN: 3.8; CONFIDENCE LIMITS: 2.3-5.7. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH THE INRATIO AND LAB VALUES ARE NOT WITHIN CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS REQUIRED AT THIS TIME. PER PR, IN-HOUSE RETAINS STRIPS LOT 060519 WERE TESTED USING THERAPEUTIC BLOOD FROM TWO DONORS. THE ACCEPTANCE CRITERIA IS AS FOLLOWS: IF THE MLA INR IS LESS THAN 2.0, THEN THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/- .05. IF THE MLA INR IS 2.0 - 4.5, THE THE ALLOWABLE DIFFERENCE BETWEEN THE INRATIO INRS AND THE MLA INR SHALL BE +/- 1.0. TEST RESULTS OF RETAINS STRIPS LOTS 060519 DONE IN 2006 ARE AS FOLLOWS: SEE SCANNED TABLE. BASED ON THE ABOVE TEST RESULTS, PER PR, RETAINED LOT 060519 MEETS THE CRITERIA FOR STRIP ACCURACY.

Description of Event or Problem · 1

CALLER ALLEGED INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: 2007: INRATIO: 1.6; LAB: NOT DONE. 2007: INRATIO: 1.4; LAB: 6.0. 2007: INRATIO: 1.4; LAB: NOT DONE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	JPA	HEMOSENSE, INC.	*	060519

Patients

Seq	Age	Sex	Outcome	Treatment
1	*