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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, Inadequate or Imprecise Result or Readings (1535)
Patient Problems Apnea (1720); Bruise/Contusion (1754); Cardiac Arrest (1762); Stroke/CVA (1770); Death (1802); Ecchymosis (1818); Hemorrhage/Bleeding (1888)
Event Date 01/06/2014
Event Type  Death  
Event Description
Caller reported potential discrepant low inratio inr result.Patient is a (b)(6) female, who is a "no code", living in a boarding care facility with a caregiver who administers her medication, it is unknown if the caregiver has any medical training.Patient experienced a cerebrovascular accident (cva) in (b)(6) 2013 and was treated with lovenox twice a day.The lovenox was discontinued on (b)(6) 2013 and the patient was started on warfarin.On (b)(6) 2014, the caregiver at the boarding care; noticed abnormal bruising; dark purple ecchymotic area on the patient's upper back to left upper arm (axilla area).Caregiver called the patient's primary care physician to report and was instructed to take the patient to urgent care for evaluation.The caregiver chose to wait for home health nurse visit.The home health nurse arrived at 10:00 am.The patient's heart rate was 109; blood pressure 100/78, no shortness of breath or dyspnea.The inratio inr result was 2.4 which was performed between 10:00 am and 11:55 am.Patient's mental status was at baseline, alert to person.During the visit, the patient had a bowel movement which was described as small, soft formed, dark brown stool, no frank blood noted.The nurse left the patient at 11:55 am.The patient was sent to the emergency room due to the abnormal bruising.The patient arrived at the emergency room at 12:20 pm.Patient had emesis of blood while in the emergency room.Laboratory testing: inr = 9.1 drawn at 12:44 pm; wbc = 18.5; hgb = 6.4; hct = 19.7.Treatment included vitamin k and fresh frozen plasma (ffp).No additional inr testing performed.The patient became apneic and went into asystole.The patient remained a "no code" at hospital and expired at 4:14 pm.The final diagnosis was gastrointestinal (gi) bleed.The coroner waived autopsy.The nurse manager reports that the staff has been using the inratio product for "several years" and are well trained on the device.The home health agency has 40 + patients, at any given time, that have their inr performed and have had no discrepant results that stand out.Multiple nurses use meters.On (b)(6) 2014, the nurse, who performed the patient's inratio testing, also performed approximately 5 inratio tests on different patient's the same day with no reported abnormal results.Since home health nurse does not fill patient's medication, the warfarin pill count, prescription refill information or residual pills is unknown.No additional information was 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 Key3611919
MDR Text Key4170422
Report Number2027969-2014-00067
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 01/07/2014
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
Device Lot Number331340
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/10/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/07/2014
Initial Date FDA Received01/29/2014
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
WARFARIN 4 MG T/TH/SAT/SUN; LOVENOX TWICE DAILY DISCOUNTINUED; DEPAKOTE; MELATONIN; ALERE INRATIO 2 PT/INR PRO MONITOR, SN #(B)(4); METOPROLOL; VITAMIN D3; LIPITOR; HYDROCHLOROTHIAZIDE (HCTZ); CLONIDINE AS NEEDED; ATIVAN AS NEEDED; NORCO, LOW DOSE ASPIRIN; WARFARIN 2 MG M/W/F
Patient Outcome(s) Death; Hospitalization; Required Intervention;
Patient Age85 YR
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