MAUDE Adverse Event Report: ALERE ALERE INR RATIO 2; PT/INR RATIO

Model Number CE0197

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 12/16/2014

Event Type  Other  

Event Description

I received a form warning of possible incorrect readings from alere pt/inr monitor system.I was in the safe parameters for hematocrit.Had no other health issues listed.Confirmed inr with lab veinous draw and from alere monitor.All within range.So no action needed and safe to continue to use the monitor.

• Brand Name: ALERE INR RATIO 2
• Type of Device: PT/INR RATIO
• Manufacturer (Section D): ALERE
• MDR Report Key: 4398674
• MDR Text Key: 5433091
• Report Number: MW5040054
• 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: 12/31/2014

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: CE0197
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2014
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 80