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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE INR MONITOR
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ALERE INR MONITOR Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  No Answer Provided  
Event Description
Nothing happened, there was no event.
 
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Brand Name
INR MONITOR
Type of Device
INR MONITOR
Manufacturer (Section D)
ALERE
*
MDR Report Key4628104
MDR Text Key15139672
Report NumberMW5041601
Device Sequence Number1
Product Code GJS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Was the Report Sent to FDA? No
Patient Sequence Number1
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