MAUDE Adverse Event Report: ALERE ALERE INRATIO PT/INR MONITOR SYSTEM; INR BLOOD TESTER, TEST STRIPS

Model Number 0100071

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/05/2014

Event Type  Injury  

Event Description

Letter received dated (b)(6) 2014 from alere notifying me of problems with my pt/inr monitor system.Alere sent replacement device to me in (b)(6) 2014.

• Brand Name: ALERE INRATIO PT/INR MONITOR SYSTEM
• Type of Device: INR BLOOD TESTER, TEST STRIPS
• Manufacturer (Section D): ALERE
• MDR Report Key: 4707073
• MDR Text Key: 5646507
• Report Number: MW5042141
• 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: 03/18/2015

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?: Yes
• Device Operator: Other
• Device Model Number: 0100071
• Other Device ID Number: 0200432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 73