BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1351794 · Received March 24, 2009

    Report

    Report Number
    2027969-2009-00155
    Event Type
    Injury
    Date Received
    March 24, 2009
    Date of Event
    March 16, 2009
    Report Date
    March 24, 2009
    Manufacturer
    BIOSITE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS REPORTABLE BECAUSE A RECURRENCE MAY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. CALLER CALLED IN 2009, AND STATED THAT THEY TESTED ANOTHER PATIENT AND GOT A 5.3 AND THEN TOOK THE SAME FINGERSTICK SITE AND DROPPED A DROP OF BLOOD ON ANOTHER METER AND PUT IT ON THE METER IN QUESTION AND GOT A 1.7. DEVICE WILL BE RETURNED FOR EVALUATION. INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS ARE AS FOLLOWS: PATIENT ORIGINALLY TESTED 5.5 ON THE METER; REPEATED TEST AND GOT A 5.6. DOCTOR HELD DOSAGE FOR THE PATIENT BUT PATIENT MAY HAVE TAKEN THE COUMADIN DOSAGE THAT DAY. PATIENT WAS TESTED THE NEXT DAY AND GOT A 3.9 ON METER. PATIENT ORIGINALLY SAID THEY DIDN'T TAKE THEIR PILLS BUT THE NURSE SAID THE PATIENT DID. THE NURSE QUESTIONED THE 3.9 BECAUSE IF THE PATIENT TOOK THE COUMADIN, IT SHOULD BE HIGHER THAN THE 5.5 AND DID A LAB DRAW. THE LAB CAME BACK WITH A 9.3; PATIENT RECEIVED AN ORAL DOSE OF VITAMIN K IN 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE, INC. 0100139

    Patients

    Seq Age Sex Outcome Treatment
    1 NI