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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 Problems Fever (1858); Pneumonia (2011)
Event Date 08/26/2014
Event Type  Injury  
Event Description
Caller alleged discrepant inratio results.Therapeutic range: 2.5-3.5.Patient self tester had a fever from (b)(6).Patient was admitted to the hospital on (b)(6) due to pneumonia.Upon admittance to hospital, the lab inr was >9.0.Patient started augmentin on (b)(6), and then switched to a "heavy duty" antibiotic while in the hospital.In the hospital the patient was also given lasix and albuterol.No vitamin k was administered.The physician would like to wait for the coumadin to clear from her system, then address the supratherapeutic values.As of (b)(6), the patient was still in the hospital.
 
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 Key4122361
MDR Text Key4942298
Report Number2027969-2014-00852
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 08/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number100071
Device Lot Number348355
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/27/2014
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
Patient Sequence Number1
Treatment
COUMADIN ON HOLD; INRATIO MONITOR SERIAL NUMBER : (B)(4)
Patient Outcome(s) Required Intervention;
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