BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6309557 · Received February 7, 2017

    Report

    Report Number
    2027969-2017-00029
    Event Type
    Death
    Date Received
    February 7, 2017
    Report Date
    January 9, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Removal / Correction Number
    Z-2354,2362-2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. AS THE PATIENT'S WIFE WAS UNABLE TO PROVIDE A LOT NUMBER, A MANUFACTURING RECORD REVIEW AND TESTING ON RESERVE SAMPLE FROM THE SAME LOT COULD NOT BE PERFORMED. FURTHER INVESTIGATION IS NOT POSSIBLE AT THIS TIME. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE PATIENT'S WIFE CALLED IN RESPONSE TO INRATIO SYSTEM WITHDRAWAL NOTIFICATION. THE PATIENT WAS REPORTED AS SOMETIMES EXPERIENCING A DISCREPANT LOW INRATIO INR RESULT AS COMPARED TO A LABORATORY METHOD. ON (B)(6) 2016, THE PATIENT RECEIVED AN INRATIO INR RESULT OF 2.9 WHILE THE PATIENT WAS TAKING A QUARTER DOSE OF SINTROM. ON (B)(6) 2016, THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR BLEEDING AND CLINICIANS WERE UNABLE TO STABILIZE HIM. THE LABORATORY INR RESULT WAS 6.0. THE PATIENT DIED FROM AN UNSPECIFIED CAUSE ON (B)(6) 2016. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90746 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| L| R INRATIO2 MONITOR, PN 200433