BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4169469 · Received October 8, 2014

    Report

    Report Number
    2027969-2014-00914
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED THAT ON (B)(6) 2014, THE PATIENT'S INRATIO INR WAS 3.6 AND THE LABORATORY INR WAS >10.0. THE TIME BETWEEN TESTING WAS TEN (10) MINUTES. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0 - 3.0. IT IS UNKNOWN IF ANY TREATMENT OR MEDICATION CHANGE WAS PERFORMED AT THAT TIME. ON (B)(6) 2014, THE PATIENT WAS HOSPITALIZED FOR HYPERTENSION. THE LABORATORY INR WAS >15.1. THE CALLER COULD NOT PROVIDE ANY INFORMATION REGARDING HOSPITALIZATION OR TREATMENT. ON (B)(6) 2014, CUSTOMER WAS CONTACTED REGARDING ADDITIONAL INFORMATION ON THE PATIENT'S HOSPITAL STAY AND OUTCOME. CUSTOMER REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2014 RELATED TO HYPOVOLEMIC SHOCK. THOUGH REQUESTED, THE CUSTOMER WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING EVENT DUE TO THEIR INTERPRETATION OF THE HIPAA REGULATION. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION WITH NO SUCCESS. ON 10/02/2014, EMAIL RECEIVED FROM CUSTOMER REPORTING THAT THE FACILITIES MEDICAL DIRECTOR REVIEWED THE CHART AND THE "PT/INR READINGS WERE UNRELATED TO THE DEATH OF THE PATIENT." NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631376 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 349870

    Patients

    Seq Age Sex Outcome Treatment
    1 89-90 Male Hospitalization| D COUMADIN| INRATIO MONITOR SN (B)(4)| INRATIO MONITOR SN (B)(4)| COUMADIN