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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 Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Unspecified Infection (1930)
Event Date 05/01/2014
Event Type  Injury  
Event Description
Caller alleged discrepant inratio results.Results as follows: date: (b)(6) 2014; inratio: 1.7; lab: 3.4; time between tests: 9 hours.Therapeutic range: 2.5-3.5.Pt self tester was admitted to the hosp on (b)(6) 2014 for an infection.Pt was administered antibiotics for the infection; no vitamin k given.Physician adjusted the pt's warfarin dose.Pt was discharged on (b)(6) 2014.
 
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 Key4012923
MDR Text Key4688637
Report Number2027969-2014-00709
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 07/03/2014
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 Lay User/Patient
Device Model Number100071
Device Lot Number334579
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/03/2014
Initial Date FDA Received07/28/2014
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 NUMBER: (B)(4); MEDICATION: WARFARIN
Patient Outcome(s) Required Intervention;
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