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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 100139
Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)
Patient Problems Erythema (1840); Overdose (1988)
Event Date 09/19/2014
Event Type  malfunction  
Event Description
Caller alleging discrepant inratio values.(b)(6) 2014 inratio greater than 7.5 repeat 4.5.Tests performed within the hour patient's therapeutic range unknown.The reporting nurse observed the patient had redness around the nostrils and noted the patient had been taking a higher dosage of coumadin than had been instructed by the physician.Coumadin prescribed 2 mg per day.Patient was taking 3 mg daily thinking they were 2 mg pills.No reported treatment or additional information provided.
 
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 Key4173050
MDR Text Key5019252
Report Number2027969-2014-00921
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 Health Professional
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 09/19/2014
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 Lay User/Patient
Device Model Number100139
Device Lot Number352445
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/19/2014
Initial Date FDA Received10/09/2014
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
INRATIO MONITOR SERIAL #(B)(4); COUMADIN
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