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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE ALERE INTRATIO 2 PT/INR HOME MONITORING SYSTEM
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ALERE ALERE INTRATIO 2 PT/INR HOME MONITORING SYSTEM Back to Search Results
Model Number 0200432
Device Problem High Test Results (2457)
Patient Problems Stroke/CVA (1770); Thrombus (2101); Ambulation Difficulties (2544)
Event Date 04/19/2014
Event Type  Injury  
Event Description
My husband used the alere pt/inr home monitoring kit for 2 years.We checked his inr every 10 days to 2 weeks.He was consistently in the therapeutic range for inr, according to the machine.We last measured his inr on (b)(6) 2014, and it was 2.5.On (b)(6) 2014, he had a massive stroke due to a clot in his left middle cerebral artery.His inr was 2.1 in the emergency department.He had the clot removed by a neuroradiologist at (b)(6) within 90 minutes of symptom onset (somnolence, global aphasia, right hemiplegia).He recovered speech but continues to have receptive aphasia and severe gait deviations and instability.In (b)(6) of 2014, we received a letter from alere titled urgent: medical device correction.The letter stated that there had been reports of recordings with the alere machine that were lower than the actual inr, so there was a risk of bleeding.We wanted to report my husband's episode, in case there had been any incident of the alere machine recordings being higher than the actual inr, which may contribute to clot formation.We did not have a problem with the device, we just wanted to report this episode, since we received the letter from alere.
 
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Brand Name
ALERE INTRATIO 2 PT/INR HOME MONITORING SYSTEM
Type of Device
ALERE INTRATIO 2 PT/INR HOME MONITORING SYSTEM
Manufacturer (Section D)
ALERE
MDR Report Key4426250
MDR Text Key5415589
Report NumberMW5040230
Device Sequence Number1
Product Code GJS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 01/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number0200432
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/11/2015
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Disability;
Patient Age74 YR
Patient Weight77
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