INRATIO PT/INR TEST STRIPS

Report

Report Number: 2027969-2016-00071
Event Type: Injury
Date Received: February 2, 2016
Date of Event: January 10, 2016
Report Date: January 12, 2016
Manufacturer: ALERE SAN DIEGO, INC.
Product Code: GJS
PMA / PMN Number: K092987
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION IS PENDING.

Description of Event or Problem · 1

ON (B)(6) 2016, A CALL WAS RECEIVED FROM A CUSTOMER (END USER) REPORTING QUALITY CONTROL ERRORS. SHE HAD CONCERNS ABOUT THE ERROR CODE "QCH" AND THOUGHT THAT THE ERROR MESSAGE MEANT THAT HER INR WAS TOO HIGH. THE FOLLOWING INFORMATION WAS RECEIVED: HISTORICAL INRATIO INR RESULTS: (B)(6) 2015: 2.7 , (B)(6) 2015: 2.8 , (B)(6) 2015: 3.3 , THERAPEUTIC RANGE: 2.5 - 3.5 . ON (B)(6) 2016, THE CALLER RECEIVED ERROR MESSAGES AND THOUGHT THAT THEY MEANT HER INR WAS HIGH SO SHE WENT TO THE HOSPITAL. AT THE HOSPITAL, THE LABORATORY INR WAS 15.9. THE CALLER WAS HOSPITALIZED. TREATMENT INCLUDED VITAMIN K ADMINISTRATION AND A BLOOD TRANSFUSION THAT EVENING. AFTER THE BLOOD TRANSFUSION, THE LABORATORY INR WAS 1.9. ON (B)(6) 2016 AT 4:45AM, THE LABORATORY INR WAS 1.6 AND THE CALLER WAS DISCHARGED. AS OF (B)(6) 2016, THE CALLER REMAINED ON THE LOVENOX THAT WAS STARTED SOMETIME DURING HOSPITALIZATION. ON (B)(6) 2016, THE CALLER TESTED AGAIN ON THE INRATIO DEVICE AND RECEIVED AN ERROR MESSAGE WHICH SHE INTERPRETED AS MEANING HER INR WAS HIGH. SHE WENT TO THE HOSPITAL AND THE LABORATORY INR WAS 1.4. DURING TESTING ON (B)(6) 2016, THE CALLER REPORTED PERFORMING MULTIPLE FINGER STICKS ON THE SAME FINGER. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
64084	INRATIO PT/INR TEST STRIPS	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC.	100071	373678A

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R