MAUDE Adverse Event Report: ALERE ALERE INRATIO PT/INR HOME MONITOR; PT/INR RATIO MONITORING

Device Problem Insufficient Information (3190)

Patient Problems Autoimmune Reaction (1733); Thrombus (2101)

Event Type  Injury  

Event Description

Intermittent medical leave blood dvt's, lovenox injections, extensive medical testing, coumadin/warfarin (b)(6) 2006, medical equipment was required.Medical event plasma, blood transfusions, immunity reactions.

• Brand Name: ALERE INRATIO PT/INR HOME MONITOR
• Type of Device: PT/INR RATIO MONITORING
• Manufacturer (Section D): ALERE
• MDR Report Key: 6056666
• MDR Text Key: 58381298
• Report Number: MW5065598
• 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: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability