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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. INRATIO RT/INR TEST STRIPS; PROTHROMBIN TIME TEST
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ALERE SAN DIEGO, INC. INRATIO RT/INR TEST STRIPS; PROTHROMBIN TIME TEST Back to Search Results
Model Number 100139
Device Problem Low Test Results (2458)
Patient Problems Hemorrhage/Bleeding (1888); Complaint, Ill-Defined (2331)
Event Date 06/30/2014
Event Type  Injury  
Event Description
Caller alleged discrepant inratio results.Results as follows: date: (b)(6), inratio: 2.1, lab: 4.2; date: (b)(6), inratio: 6.2.Time between tests: less than one hour.Therapeutic range: 2.0-3.0.No adjustment to coumadin dose was made on (b)(6) because the lab result did not come back until (b)(6).Patient was admitted to the e.R.On (b)(6) due to bleeding out and not feeling well.Nurse believes the patient is still in the hospital, but will not have access to more information until the patient is discharged, as the patient is at a different hospital.
 
Manufacturer Narrative
Investigation pending.
 
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Brand Name
INRATIO RT/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 Key4029902
MDR Text Key14880212
Report Number2027969-2014-00715
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 Nurse
Type of Report Initial
Report Date 07/10/2014
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 Number345310
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/21/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/10/2014
Initial Date FDA Received07/31/2014
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
MEDICATIONS: COUMADIN; INRATIO MONITOR SERIAL NUMBER: (B)(4)
Patient Outcome(s) Hospitalization; Required Intervention;
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