MAUDE Adverse Event Report: ALERE ALERE INRATIO METER

Device Problem High Readings (2459)

Patient Problems Death (1802); Intracranial Hemorrhage (1891); Test Result (2695)

Event Date 02/10/2016

Event Type  Death  

Event Description

Home health nurse had been monitoring (b)(6)'s coumadin levels by using alere inratio meter and strips.We were notified that a regular blood draw from the arm showed a level of 8 even though previous meter readings had registered in normal level.This blood draw was on (b)(6) 2016 and a f/u by the alere meter showed a 1.7.Mr.(b)(6) was admitted to the hospital with a brain bleed on (b)(6) 2016 and died as a result of the bleed on (b)(6) 2016.

• Brand Name: ALERE INRATIO METER
• Type of Device: ALERE INRATIO METER
• Manufacturer (Section D): ALERE
• MDR Report Key: 5690682
• MDR Text Key: 46264681
• Report Number: MW5062534
• 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: Other
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 82 YR
• Patient Weight: 113