BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3611919 · Received January 29, 2014

    Report

    Report Number
    2027969-2014-00067
    Event Type
    Death
    Date Received
    January 29, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 7, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62625 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2 331340

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| H| R 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