FDA Adverse Event Malfunction Summary report: N

INRATIO

MDR report key: 3802315 · Received February 20, 2014

Report

Report Number: 2027969-2014-00148
Event Type: Malfunction
Date Received: February 20, 2014
Date of Event: January 29, 2014
Report Date: January 29, 2014
Manufacturer: ALERE SAN DIEGO, INC
Product Code: GJS
PMA / PMN Number: K092987
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. A REVIEW OF THE BATCH RECORD FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT SYSTEM FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME. THE ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: INITIAL INRATIO: ERROR; 1ST RE-TEST: 0.9; 2ND RE-TEST: 3.0; ALL TESTS TAKEN WITHIN 1 HOUR. THERAPEUTIC RANGE: 2.0-3.2. PT SELF TESTER USED THE SAME FINGER FOR THE INITIAL AND FIRST RE-TEST. A NEW FINGER WAS PRICKED FOR THE SECOND RE-TEST. CALLER ALSO REPORTS THAT TESTS WERE PERFORMED WHILE THE INRATIO METER WAS ON A CARDBOARD BOX.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
106530	INRATIO	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC	100071	329655

Patients

Seq	Age	Sex	Outcome	Treatment
1				MEDICATION: WARFARIN