BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3922469 · Received June 2, 2014

    Report

    Report Number
    2027969-2014-00524
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADDITIONAL INFO. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW WAS NOT PERFORMED AND FURTHER INVESTIGATION WAS NOT POSSIBLE. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: INRATIO: 0.8, LAB: 2.1. TIME BETWEEN TESTS: 3 HOURS. THERAPEUTIC RANGE: UNK. PT SELF TESTER WENT TO THE ER FOR DIZZINESS AFTER RECEIVING 0.8 INR ON HER INRATIO MONITOR. THE PTS BLOOD WAS DRAWN AT THE ER; INR=2.1. PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY. DISCHARGE DIAGNOSE WAS NOT AVAILABLE, BUT THE PT STATED HER DIZZINESS WAS NOT RELATED TO HER INR. THE PT SELF TESTER DOES NOT HAVE ANY STRIPS FROM THE LOT REMAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320918 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN 2.5MG 2X/DAY| VICODEN (AS NEEDED)| KEPPRA 500 MG 2XDAY