FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 1686429 · Received May 10, 2010

Report

Report Number: 2027969-2010-00561
Event Type: Malfunction
Date Received: May 10, 2010
Date of Event: November 2, 2009
Report Date: May 10, 2010
Manufacturer: BIOSITE INCORPORATED
Product Code: JPA
PMA / PMN Number: K021923
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: THREE HOURS IS CONSIDERED A REASONABLE LENGTH OF TIME BETWEEN TWO READINGS IN ORDER FOR COMPARISON TO BE VALID. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES OF TEST 1 FALLS OUTSIDE THE LIMITS, SO THE CRITERIA IS NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. STRIP L/N: 80731A HAS EXPIRED ON THE LAST DAY OF (B)(6) 2009. PREVIOUS INVESTIGATION ON STRIP L/N: 80731A FROM EVENT (B)(4) (NETRM) HAVE MET THE CRITERIA FOR ACCURACY. NO FURTHER INVESTIGATION WILL BE PURSUED. CUSTOMER USING EXPIRED STRIPS CAUSED INCORRECT READING. DEVICE WAS USED IN WAYS NO ANTICIPATED BY THE MANUFACTURER. DUE TO THE LOW OCCURRENCE OF THE ISSUE, THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. NO CORRECTIVE ACTION OR VIGILANCE REPORT IS REQUIRED AT THIS TIME. CUSTOMER ALSO USED INRATIO2 DEVICE 510 (K) 072727. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO	PROTHROMBIN TIME TEST	JPA	BIOSITE INCORPORATED	100139	080731A

Patients

Seq	Age	Sex	Outcome	Treatment
1