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

Model Number 28184

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

Received letter about conditions that instrument may not be used during these conditions.Following instructions of warning letter to report online.

• Brand Name: ALERE INRATIO PT/INR MONITORING SYSTEM
• Type of Device: ALERE INRATIO PT/INR MONITORING SYSTEM
• Manufacturer (Section D): ALERE
• MDR Report Key: 4438989
• MDR Text Key: 21448754
• Report Number: MW5040308
• 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: 01/14/2015

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
• Device Model Number: 28184
• Device Lot Number: REV A
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2015
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 82