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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST
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ALERE SAN DIEGO, INC. INRATIO PT/INR TEST STRIPS; PROTHROMBIN TIME TEST Back to Search Results
Model Number 100071
Device Problem Low Test Results (2458)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2014
Event Type  malfunction  
Event Description
Customer reported a discrepant low result when testing with inratio.There was 48 hours between the two tests; inratio = 2.8 vs.Lab inr = 6.6.Patient self tester's therapeutic range is: 2.0 - 3.0.Patient self tester was not using the first drop of blood when performing the inratio testing.List of medications was not provided but patient states there were no recent changes in his meds.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
INRATIO PT/INR TEST STRIPS
Type of Device
PROTHROMBIN TIME TEST
Manufacturer (Section D)
ALERE SAN DIEGO, INC.
san diego CA
Manufacturer Contact
ya-ling king
9975 summers ridge rd
san diego, CA 92121
8588052084
MDR Report Key4384813
MDR Text Key5125272
Report Number2027969-2014-01101
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number100071
Device Lot Number348948
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
MONITOR, SN (B)(4); WARFARIN
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