BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 3697622 · Received February 27, 2014

    Report

    Report Number
    2027969-2014-00174
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    January 30, 2014
    Report Date
    February 10, 2014
    Manufacturer
    ALERE SAN DEIGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULT SHOWS:" DATE: (B)(6) 2014; INRATIO - 2.4; LAB - 13.6. THERAPEUTIC RANG; NOT PROVIDED. PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 FOR HEMATURIA. THE ASSESSMENT OF PT WAS HE WAS A (B)(6) YEAR OLD MALE AND PLAN OF TREATMENT WAS TO REVERSE HEMATURIA WITH ONE MVK AND HOLD COUMADIN AND MONITOR DAILY. PT WAS DISCHARGED ON (B)(6) 2014 AND ADMINISTERED 180 MG T.I.D. VERAPAMIL, 25 MG T.I.D METOPROLOL, 250 MICROGRAMS DIGOXIN MCG DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122905 INRATIO PROTHROMBIN TIME SHEET GJS ALERE SAN DEIGO, INC 100139 312534

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R DIGOXIN MCG - 250 MICROGRAMS DAILY| BID METAPROLO - 25 MG| BID VERAPMAIL - 180 MG| COUMADIN, PERCOSET