BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2

    MDR report key: 1293507 · Received January 23, 2009

    Report

    Report Number
    2954730-2009-00019
    Event Type
    Injury
    Date Received
    January 23, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 22, 2009
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN 2009 PER TECHNICAL SERVICE REPRESENTATIVE, CUSTOMER HAD THREE PATIENTS THAT HAD TO UNDERGO HOSPITALIZATION (ER) DUE TO INACCURATE READINGS FROM THE METER. HOWEVER, THE CUSTOMER WASN'T ABLE TO PROVIDE ANY INRATIO AND LAB RESULTS WHEN REPORTED TO TECH SERVICE. HENCE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE NOR TO CONFIRM ANY INACCURATE READINGS FROM THE METER AS INDICATED BY THE CUSTOMER. AS OF THE SAME DAY, THE METER IS NOT EXPECTED TO RETURN. HENCE, NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    IN EARLY 2009, CUSTOMER ALLEGES SERIOUS ISSUES WITH INRATIO 2 METER; THEY HAVE HAD 3 PATIENTS GO TO THE ER TO BE HOSPITALIZED DUE TO HIGH LEVELS IN WHICH THEIR METER, THE WEEK PRIOR REPORTED ON ALL THREE FORMAL RANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 0200431

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization