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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE INRATIO
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ALERE INRATIO Back to Search Results
Device Problem Inadequate or Insufficient Training (1643)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2015
Event Type  Other  
Event Description
Alere home monitoring is replacing the recalled inratio meter with another manufacturer's meter.They are failing to provide any training to patients on these new meters.Fda guidelines require training for patients using home inr meters.
 
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Brand Name
INRATIO
Type of Device
INRATIO
Manufacturer (Section D)
ALERE
MDR Report Key4603676
MDR Text Key16076359
Report NumberMW5041380
Device Sequence Number1
Product Code GJS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Patient Sequence Number1
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