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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE INRRATIO2 MONITOR
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ALERE INRRATIO2 MONITOR Back to Search Results
Model Number 0200432
Device Problem Low Test Results (2458)
Patient Problem Overdose (1988)
Event Date 10/22/2014
Event Type  Injury  
Event Description
I was using the home inratio monitor with test strips.My inr kept going down and my dr would adjust the coumadin.This went on for a few tests.When i spoke to my dr with the last reading still going down he sent me to the hosp to have them test it and theirs showed that the machine was giving the wrong results.I then sent the machine back and told them that i did not trust it anymore.The dr maintain my blood level on the high side due to 2 blood clots one before coumadin and one after being on coumadin so the inaccuracy of the machine would of turned life threatening if i had not questioned the results.The item that caught my attention was the date on the machine had gone nuts.I am currently having my blood tested by my dr who sends it to a lab.Basically i was being given more coumadin to raise my inr when actually it was high and should have been reducing the dosage.As this was all based on the machines results which were wrong if this had been ignored i could of been in a life threatening situation.
 
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Brand Name
INRRATIO2 MONITOR
Type of Device
INRRATIO2 MONITOR
Manufacturer (Section D)
ALERE
MDR Report Key4364846
MDR Text Key5117339
Report NumberMW5039802
Device Sequence Number1
Product Code GJS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 12/19/2014
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? Yes
Device Operator Lay User/Patient
Device Model Number0200432
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/19/2014
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
Patient Weight112
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