BEUDAMED
    FDA Adverse Event Other Summary report: N

    INRATIO

    MDR report key: 2061302 · Received April 5, 2011

    Report

    Report Number
    2027969-2011-00716
    Event Type
    Other
    Date Received
    April 5, 2011
    Date of Event
    March 12, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    "CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 5.4, 1.7. PT TESTED ON TWO DIFFERENT LOTS. ON (B)(6) 2011 PT TESTED AT 1PM AND GOT AN INR = 5.4 USING STRIP LOT 243934. ON (B)(6) 2011 PT TESTED AT 3PM AND GOT AN INR = 1.7 USING STRIP LOT 233708. ON SATURDAY HE WAS CONCERNED BECAUSE HE SAW BLOOD IN THE MUCUS WHEN HE BLEW HIS NOSE OR COUGHED. HE WAS TAKING MUCINEX AND NYQUIL FOR HIS CONGESTION. ON SUNDAY HE DID NOT NOTICE ANY BLOOD AND WAS NOT COUGHING AND THE CONGESTION HAD CLEARED. HE MAY HAVE TAKEN ONE TYLENOL OVER THE WEEKEND, BUT DOES NOT REMEMBER WHEN. THE FIRST TIME HE TESTED HE REC'D 444 ERROR AND COMMENTED HE DID NOT HAVE ENOUGH BLOOD. PT SAYS HIS FINGERS ARE BRUISED AND SORE FROM TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 100071 243934

    Patients

    Seq Age Sex Outcome Treatment
    1 Other