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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 Low Test Results (2458)
Patient Problems Abdominal Pain (1685); Fever (1858); Hemorrhage/Bleeding (1888); Sore Throat (2396)
Event Date 07/14/2014
Event Type  Injury  
Event Description
Caller alleged discrepant inratio results.Results as follows: date: (b)(6) 2014; inratio: 4.0; re-test: 4.0; lab: 19.0; time between tests: minutes.Therapeutic range: 2.0-3.0.On (b)(6) 2014: pt had a one month follow up appointment with dr (b)(6) to discuss history and hosp issues.The pt has not been feeling well for a few days, with an off and on fever, sore throat and abdominal pain.In addition the pt's gerd and stomach have acting up; no vomiting or diarrhea.The pt's inr was drawn today; inr=7.5.Her last inr draw was 1.6 and over 5 the week before.The pt reports that her gums have been bleeding a little with toothbrushing, but no other reports of bleeding.There has been no change in shortness of breath (sob).The pt has continued to take prothrombin time (pt) at home and can only do short bursts of activity.The pt's vitamin d level is to be checked as she had an infusion of it recently.The doctor discussed treatment options with the pt, including hospitalization.The pt declined being admitted to the hosp.And was given 500mg vitamin k by mouth.The doctor will try to bring the pt's inr down slightly without dropping it sub-therapeutic.The pt will not be taking coumadin this week.The doctor also discussed that fluconazole will also potentially increase inr.
 
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 Key4023895
MDR Text Key4723692
Report Number2027969-2014-00753
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 07/15/2014
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 Number343592
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/18/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/15/2014
Initial Date FDA Received08/13/2014
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
PREDNISONE 32.5; SPIRONOLACTONE 50MG; ALBUTEROL; FERROUS SULFATE 325MG; FENTANYL; PROTONIX 40MG; SPRIVA 18MCG; ZOFRAN 4MG; MEXILETINE 25MG; TOPROL XL 50MG; CULTURELLE; LASIX; FLUCONAZOLE 100MG; ERGOCALCIFEROL 50,00U; COLCHICINE; SYMBICORT; GABAPENTIN 300MG; TYLENON 650 MG; MORPHINE 30MG; LYRICA 25MG; VANCOCIN 125MG; COUMADIN; INRATIO MONITRO, SN 092052367; INVANZ 1,00MG IN SODIUM CHLORIDE
Patient Outcome(s) Required Intervention;
Patient Age43 YR
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