FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 873532 · Received June 29, 2007

Report

Report Number: 2954730-2007-00298
Event Type: Malfunction
Date Received: June 29, 2007
Date of Event: June 26, 2007
Report Date: June 27, 2007
Manufacturer: HEMOSENSE, INC.
Product Code: ---
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2007; LAB: 8.2; MEAN: 5.6; CONFIDENCE LIMITS: CANNOT BE DETERMINED; DATE: 2007; INRATIO: 2.3; LAB: 5.4; MEAN: 3.85; CONFIDENCE LIMITS: 2.3-5.7. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, THE MEAN > 5.0 AND DIFFERENCE BETWEEN INR'S > 2.2, , THE VALUES WERE CONSIDERED INACCURATE. PRODUCTS WILL BE TESTED. FOR THE SECOND SET OF DATA, BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME. PER TEXT" HAD STREPTOCOCCUS INFECTION AND ARTHRITIS DURING THE WEEKS (MEDICATION: ANTIBIOTICS, AMBENE) "PATIENT'S CONDITION MAY CAUSE THE DISCREPANCY. THE TEST RESULTS OF RETAINS STRIPS LOTS 060656 DONE IN 2007, ARE AS FOLLOWS: BASED ON THE ABOVE TEST RESULTS, RETAINED LOT 060656 MEETS THE CRITERIA FOR STRIP ACCURACY.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007; INRATIO: 3.0; LAB: 8.2; DATE: 2007; INRATIO: 2.3; LAB: 5.4.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	---	HEMOSENSE, INC.		060656

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR