MAUDE Adverse Event Report: ALERE INRATIO 2; PT/INR MONITOR

Device Problems Nonstandard Device (1420); Appropriate Term/Code Not Available (3191)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/01/2016

Event Type  Other  

Event Description

Caller complained that the machine was recalled by the manufacturer and he is not being compensated for the cost he incurred in purchasing it.The fda should do something about this.

• Brand Name: INRATIO 2
• Type of Device: PT/INR MONITOR
• Manufacturer (Section D): ALERE
• MDR Report Key: 5910084
• MDR Text Key: 53500286
• Report Number: MW5064374
• 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: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 139