MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. ALERE INRATIO PT/INR MONITORING SYSTEM; PT/INR MONITOR SYSTEM

Model Number MULTIPLE UNITS 122428056

Device Problems High Test Results (2457); Device Operates Differently Than Expected (2913)

Patient Problem Test Result (2695)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Add'l info received on 12/16/2014.Alere inratio pt/inr monitor system used to check inr.Results were consistent 1.6 - 1.9 over a week.It went to md and lab reported inr 5.3, bp 80/60.Admitted to hospital for hypercoagulation.Multiple nurses used multiple monitors and all results were low.Notified on (b)(4) 2014 that pt's pt/inr was high, hypotension and was enroute to er for admission.Pt admitted to hospital with bp 80/60, inr 5.3.Received urgent medical device connector dated (b)(6) 2014 for alere on (b)(6) 2014 notifying us of issues with pt/inr monitoring system.We pulled pt/inr machine out of use and pt/inr will be by venipuncture only.Dates of use: (b)(6) 2014.

Event Description

Alere inratio pt/inr monitor system used to check inr.Results were consistent 1.6-1.9 over a week.It went to md and lab over a week.It went to md and lab reported inr 5.3 bp 80/60.Admitted to hospital for hypercoagulation.Multiple nurses used multiple monitors and all results were low.Diagnosis or reason for use: aaa repair, dvt femoral vein.

• Brand Name: ALERE INRATIO PT/INR MONITORING SYSTEM
• Type of Device: PT/INR MONITOR SYSTEM
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd; san diego CA 92121
• MDR Report Key: 4360705
• MDR Text Key: 5508973
• Report Number: MW5039722
• Device Sequence Number: 1
• Product Code: GJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MULTIPLE UNITS 122428056
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Weight: 81