BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 2102604 · Received May 20, 2011

    Report

    Report Number
    2027969-2011-01125
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K021923
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, LAB: 2.6, INRATIO: 1.7, THERAPEUTIC RANGE: (AROUND 2.0). FORTY FIVE (45) MINUTES LATER PT TESTED ON HIS INRATIO METER AND GOT 1.7. PT WENT FROM 2000 MG TO 6000 MG OF FISH OIL A FEW MONTHS AGO (DATE NOT GIVEN), BECAUSE HE IS NOT ABLE TO TAKE STATINS AND HIS PHYSICIAN SAID THIS WOULD HELP. PT NOTICED INITIALLY THAT THE FISH OIL DECREASED HIS INR SO HIS COUMADIN WAS INCREASED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 243103

    Patients

    Seq Age Sex Outcome Treatment
    1 NI