INRATIO PT/INR TEST STRIPS

MDR report key: 5734057 · Received June 17, 2016

Report

Report Number: 2027969-2016-00456
Event Type: Malfunction
Date Received: June 17, 2016
Date of Event: May 19, 2016
Report Date: May 20, 2016
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K110212
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

Additional Manufacturer Narrative · 1

INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K372402 WAS FOUND TO BE PERFORMING WITHIN EXPECTATIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO RELEVANT NON-CONFORMANCE'S WERE DOCUMENTED. THE CUSTOMER WAS USING EXPIRED PRODUCT. USE OF PRODUCT BEYOND ITS EXPIRATION DATE CAN RESULT IN ERRORS OR INACCURATE RESULTS. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. 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

REPORT RECEIVED OF DISCREPANT INRATIO VALUES. EVENT OCCURRED IN (B)(6). PATIENT'S THERAPEUTIC RANGE 2 .0 - 3.0. ON (B)(6) 2016, PATIENT PERFORM COMPARATIVE MEASUREMENTS IN DOCTOR'S OFFICE. INRATIO2 INR = 1.5; CC XS (OTHER POC SYSTEM) INR = 2.3; LAB INR = 2.9. HISTORICAL VALUES: ON (B)(6) 2016 INRATIO2 INR = 1.5. ON (B)(6) 2016 INRATIO2 INR = 1.6. ON (B)(6) 2016 INRATIO2 INR = 1.6. ON (B)(6) 2016 INRATIO2 INR = 1.2. NO REPORTED ADVERSE PATIENT SEQUELA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
386328	INRATIO PT/INR TEST STRIPS	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	99008G1	K372402

Patients

Seq	Age	Sex	Outcome	Treatment
1