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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 Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem Test Result (2695)
Event Date 06/03/2014
Event Type  Injury  
Event Description
Caller alleged discrepant inratio results.Results as follows: date: (b)(6), inratio: greater than 7.5, 5.6, lab: 13.0.Inratio tests were separate finger sticks performed back to back.All tests conducted within 15 minutes.Therapeutic range: 2.5-3.0.Vitamin k was administered on (b)(6) based on lab result.
 
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 Key4001596
MDR Text Key4956522
Report Number2027969-2014-00617
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 Other,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/03/2014
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 Health Professional
Device Model Number100139
Device Lot Number341996
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/23/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/03/2014
Initial Date FDA Received06/27/2014
Was Device Evaluated by Manufacturer? No
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
BACTRIM (TAKEN 5/24-6/2) 10 DAY PRESCRIPTION; INRATIO MONITOR SERIAL NUMBER: (B)(4); ROCEPHIN (1G ADMINISTERED 5/24); MEDICATIONS: WARFARIN (4MG X2/WEEK, 6MG X5/WEEK)
Patient Outcome(s) Required Intervention;
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