MAUDE Adverse Event Report: ALERE INRATIO PT/INR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 05/27/2015

Event Type  Other  

Event Description

Was prescribed an alere inratio pt/inr monitoring system.Prescription was never filled.

• Brand Name: INRATIO PT/INR
• Type of Device: INRATIO PT/INR
• Manufacturer (Section D): ALERE
• MDR Report Key: 4810404
• MDR Text Key: 5919106
• Report Number: MW5042868
• 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: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2015
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 77