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

Model Number INRATIO 2

Device Problem Insufficient Information (3190)

Patient Problem Headache (1880)

Event Date 08/03/2016

Event Type  Injury  

Event Description

Alere inr ratio machine testing blood levels extremely thin.Had been using monitor for years then on (b)(6) 2016 levels tested 6.0 and 6.4.Next morning (took warfarin night before) inr was 3.8.I knew immediately something was wrong.I had felt a little lightheaded on (b)(6) 2016 as to why i took reading.

• Brand Name: INRATIO 2 PT/INR HOME MONITOR
• Type of Device: INRATIO 2 PT/INR HOME MONITOR
• Manufacturer (Section D): ALERE
• MDR Report Key: 5972734
• MDR Text Key: 55613881
• Report Number: MW5064978
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: INRATIO 2
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BENTYL AS NEEDED; OTC MEDS: SEE ABOVE. ; RX MEDS: WARFARIN HYDROCHLORTHIAZIDE; SPIRONOLACTONE; VITAMIN B12 INJECTION; VITAMIN D3; XYZAL AS NEEDED; ZOFRAN AS NEEDED
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 98