FDA Adverse Event Malfunction Summary report: N

INRATIO2

MDR report key: 3831942 · Received March 6, 2014

Report

Report Number: 2027969-2014-00185
Event Type: Malfunction
Date Received: March 6, 2014
Date of Event: February 11, 2014
Report Date: February 28, 2014
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K092987
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

IT IS INDICATED THAT PRODUCT IS NOT RETURNED 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, RETAIN TESTING WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. 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. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: DATE: (B)(6) 2014, INRATIO: 2.6, LAB: 4.6 (1 HOUR APART). DATE: (B)(6) 2014, INRATIO: 2.6, LAB: 4.5 (1 HOUR APART). THERAPEUTIC RANGE FOR CARDIOVERSION: 3.0-3.5; REGULAR THERAPEUTIC RANGE: 2.3. PATIENT SELF TESTER IS MONITORING INR FOR A CARDIOVERSION PROCEDURE SCHEDULED FOR (B)(6) 2014.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
136015	INRATIO2	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	100071	315104

Patients

Seq	Age	Sex	Outcome	Treatment
1