MAUDE Adverse Event Report: ALERE PT/INR MONITORING SYSTEM

Model Number INRATIO2 PM:28184

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802); Headache (1880); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Cancer (3262)

Event Date 04/23/2014

Event Type  No Answer Provided  

Event Description

My wife, (b)(6), had been taking warfarin for afib since 2010.She began using the alere inratio pt/inr monitor system and test strips in 2012 doing self test at home.On (b)(6) 2014, (b)(6) had colon surgery.She had stage 3 colon cancer.While in the hospital, she was given heparin.When she left the hospital, the doctor told her to start taking warfarin immediately.She did.Her test results were 2.5-3.5.(b)(6) was recovered from her operation.She did have infections.On (b)(6) 2014, her test result was 2.8.On (b)(6) 2014, i had an ambulance take (b)(6) to emergency for severe headaches.Her inr reading was over 5.She had bleeding on the brain and a stroke.(b)(6) did not come back home.She died on (b)(6) 2014 in (b)(6).

• Brand Name: PT/INR MONITORING SYSTEM
• Type of Device: PT/INR MONITORING SYSTEM
• Manufacturer (Section D): ALERE
• MDR Report Key: 4423697
• MDR Text Key: 5373432
• Report Number: MW5040212
• 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: 01/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: INRATIO2 PM:28184
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 76 YR
• Patient Weight: 41