BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE INRATIO 2 PT/INR STRIPS

    MDR report key: 3820299 · Received May 15, 2014

    Report

    Report Number
    MW5036132
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ALERE
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INR WAS SUBTHERAPEUTIC USING TEST STRIPS. DIAGNOSIS OR REASON FOR USE: PULMONARY EMBOLISM (ON WARFARIN THERAPY-NEEDS INR CHECKED). EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291484 ALERE INRATIO 2 PT/INR STRIPS PT/INR GJS ALERE PN 99008G2

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR TRAZAMINE 50 MG AT BEDTIME AS NEEDED| METFORMIN 1000 MG TWICE DAILY| SIMVASTATIN 40 MG DAILY| NOVOLIN R SLIDING SCALE| LANTUS 20 UNITS AT BEDTIME| MOBIC 15 MG DAILY| POTASSIUM CHLORIDE 20 MEQ DAILY| ATENOLOL 25 MG TWICE DAILY| FLOMAX 0.4 MG 1 DAILY FOR KIDNEY STONE| FUROSEMIDE 40 MG DAILY| GABAPENTIN 300 MG TWICE DAILY| ZYRTEC 10 MG DAILY| FLONASE 1 SPRAY DAILY| CYMBALTA 60 MG DAILY| OXYCODONE 10 MG EVERY 4-6 HOURS AS NEEDED| NEXIUM 20 MG DAILY| LISINOPRIL 20 MG DAILY| VENTOLIN AS NEEDED| FLEXERIL 10 MG DAILY| OXYCOTIN 30 MG EVERY 12 HOURS| COUMADIN 15 MG DAILY