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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO INC INRATIO PT/INR TEST STRIP; PROTHROMBIN TIME TEST
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ALERE SAN DIEGO INC INRATIO PT/INR TEST STRIP; PROTHROMBIN TIME TEST Back to Search Results
Model Number 99008G2
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problems Eye Injury (1845); Hemorrhage/Bleeding (1888); Toxicity (2333)
Event Date 02/25/2014
Event Type  Injury  
Event Description
Caller alleged discrepant low inratio2 inr result in comparison to the laboratory inr result.Customer reports, that on (b)(6) 2014, the patient called the nurse stating, "my eyes are bleeding, can you come and look at them?" the nurse performed inratio2 inr which was 3.0.The patient's left eye had gotten worse over the past hour.The patient was admitted to the hospital with a diagnosis of coumadin toxicity and conjunctival hemorrhage.The laboratory inr at 13:45 was 9.6.The patient was treated with vitamin k and fresh frozen plasma (ffp).The patient's hematocrit upon admission was 38.7.Although requested, there was no additional information provided.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
INRATIO PT/INR TEST STRIP
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 Key3720520
MDR Text Key4275834
Report Number2027969-2014-00254
Device Sequence Number1
Product Code GJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/26/2014
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 Number99008G2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2014
Initial Date FDA Received03/19/2014
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
MUCINEX 600MG TWICE DAILY; COUMADIN; HYDROCHLOROTHIAZIDE 25MG DAILY; FLUOXETINE 20MG DAILY; LEVOTHYROXINE 100MG DAILY; LISINOPRIL 40MG DAILY; SIMVASTATIN 20MG AT BED; METOPROLOL TARTRATE 25MG 1/2 TAB TWICE DAILY; OXYGEN 2 LITERS NASAL CANNULA CONTINUOUSLY; IBUPROFEN 200MG EVERY 4 HR AS NEEDED FOR PAIN; INRATIO2 PT/INR PRO MONITOR: SN (B)(4); AMLODIPINE BESYLATE 10 MG DAILY
Patient Outcome(s) Hospitalization; Required Intervention;
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