FDA Adverse Event Malfunction Summary report: N

INRATIO PT/INR TEST STRIP

MDR report key: 3912363 · Received May 13, 2014

Report

Report Number: 2027969-2014-00435
Event Type: Malfunction
Date Received: May 13, 2014
Date of Event: April 29, 2014
Report Date: April 29, 2014
Manufacturer: ALERE SAN DIEGO, INC
Product Code: GJS
PMA / PMN Number: K092987
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER

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. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THERE COULD NOT BE RULED OUT AS A CAUSE OF THE UNEXPECTED RESULTS. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE NON-CONFORMANCE ASSOCIATED WITH THIS LOT WAS NOT RELEVANT TO THE INITIAL COMPLAINT AND DOES NOT AFFECT PRODUCT PERFORMANCE. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

Description of Event or Problem · 1

CALLER ALLEGING RECEIVING DISCREPANT INRATIO VALUES. ON (B)(6) 2014, INRATIO: 4.5, REPEAT INRATIO: 2.0. TESTS CONDUCTED FIVE MINUTES APART. PT'S THERAPEUTIC RANGE 2.5 - 3.5.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
285584	INRATIO PT/INR TEST STRIP	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC	100071	334580

Patients

Seq	Age	Sex	Outcome	Treatment
1				UNSPECIFIED PAIN KILLER\| INRATIO MONITOR SERIAL # UNK\| COUMADIN