FDA Adverse Event Malfunction Summary report: N

INRATIO/INRATIO2 TEST STRIPS

MDR report key: 3813552 · Received March 26, 2014

Report

Report Number: 2027969-2014-00272
Event Type: Malfunction
Date Received: March 26, 2014
Date of Event: March 13, 2014
Report Date: March 13, 2014
Manufacturer: ALERE SAN DIEGO INC.
Product Code: GJS
PMA / PMN Number: K092987
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NM, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED FOR THE REPORTED LOT NUMBER. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES RELATED TO THIS COMPLAINT. NO FURTHER INFORMATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO INR: 5.7 AND 2.2, THERAPEUTIC RANGE: 2.0-3.0. THE TIME BETWEEN TESTING WAS SIX (6) MINUTES. THERE WAS NO REPORTED ADVERSE PT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
176892	INRATIO/INRATIO2 TEST STRIPS	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO INC.	100071	333862

Patients

Seq	Age	Sex	Outcome	Treatment
1				INRATIO 2 PT/INR PST MONITOR: SN (B)(4)\| COUMADIN