INRATIO2

MDR report key: 2881149 · Received December 14, 2012

Report

Report Number: 2027969-2012-01699
Event Type: Injury
Date Received: December 14, 2012
Date of Event: November 15, 2012
Report Date: December 14, 2012
Manufacturer: ALERE SAN DIEGO, INC
Product Code: GJS
PMA / PMN Number: K092987
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION PENDING.

Description of Event or Problem · 1

CALLER ALLEGED DISCREPANT INRATIO2 RESULTS. RESULTS AS FOLLOWS: HISTORICAL INRATIO RESULTS IN (B)(6): 1.6, 3.8 AND 6.0. DATE: (B)(6) 2012, INRATIO: 5.0, LAB:11.1. ON (B)(6) 2012, 3.2, 4.0. ON (B)(6) 2012, 4.7, ALTERNATE POC: 5.1. THERAPEUTIC RANGE: 3.5-4.0, PATIENT WAS HOSPITALIZED RELATED TO INR RESULT ON TWO INSTANCES. PATIENT EXPERIENCED A STROKE ON (B)(6) AND WAS HOSPITALIZED UNTIL (B)(6). PATIENT WAS ALSO SENT TO THE EMERGENCY ROOM ON (B)(6) YIELDING A LAB VALUE OF 11.1 (COMPARED TO INRATIO VALUE OF 5.0). THE LAB VALUE PROMPTED COUMADIN TO BE WITHHELD. PATIENT WAS ADMINISTERED HEPARIN DURING HOSPITALIZATION FOR STROKE ON (B)(6). PATIENT WAS DISCHARGED ON (B)(6), BUT BELIEVES HEPARIN ADMINISTRATION WAS TERMINATED ON (B)(6).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INRATIO2	PROTHROMBIN TIME TEST	GJS	ALERE SAN DIEGO, INC	100071	291557

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization	ALTERNATE POC DEVICE IS A COAGUCHECK METER\| MDECATION: COUMADIN (5MG AND 2.5MG ALTERNATING\| DAILY).