MAUDE Adverse Event Report: ALERE ALERE INRATIO PT/INR MONITOR SYSTEM

Model Number INRATIO 2 MONITOR

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Thrombus (2101)

Event Date 10/19/2013

Event Type  Injury  

Event Description

In was on warfarin in (b)(6) 2013 and using the alert in pt/inr monitor system.System showed safe blood levels but get blood clots and was hospitalized for one week.I have lung cancer and was on six month monitoring of year three.The ct scan for blood clots showed blood clots and that cancer metastatic.Now doing daily lovenox shots.

• Brand Name: ALERE INRATIO PT/INR MONITOR SYSTEM
• Type of Device: PT/INR MONITOR SYSTEM
• Manufacturer (Section D): ALERE
• MDR Report Key: 4397867
• MDR Text Key: 15820884
• Report Number: MW5040035
• Device Sequence Number: 1
• Product Code: GJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INRATIO 2 MONITOR
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 56 YR
• Patient Weight: 112