BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 9079841 · Received September 17, 2019

    Report

    Report Number
    2027969-2019-00388
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    April 18, 2012
    Report Date
    October 14, 2019
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TOCOMMON DEVICE NAME: GIS CORRECTED TO GJS. ADDITION TO PMA/510K: 510K NUMBER ADDED. INVESTIGATION CONCLUSION: INVESTIGATION OF THE PRODUCT COULD NOT BE PURSUED DUE TO THE CUSTOMER NOT BEING ABLE TO PROVIDE A LOT NUMBER. TESTING OF PRODUCT COULD NOT BE PERFORMED DUE TO THE PRODUCT BEING WITHDRAWN FROM THE MARKET AND ALL EXISTING PRODUCT HAVING EXPIRED IN JULY 2017. ALERE HAS WITHDRAWN THE ALERE INRATIO®/INRATIO®2 PT/INR SYSTEM FROM THE MARKET AND IS NO LONGER MANUFACTURING ALERE INRATIO® TEST STRIPS AND MONITORS. IN ADDITION, ALL ALERE INRATIO® TEST STRIPS ARE NOW EXPIRED.

    Additional Manufacturer Narrative · 1

    RESULTS PENDING INVESTIGATION COMPLETION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE DISTRIBUTOR REPORTED THAT A PATIENT WAS CLAIMING SERIOUS INJURY. THE PATIENT INDICATED THAT HE HAD A TRANSIENT ISCHEMIC ATTACK AFTER USING THE INRATIO METER WITH NO TIME FRAME GIVEN ABOUT WHEN THE TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. THE PATIENT'S RESULT WAS 2.6 WITH A THERAPEUTIC RANGE OF 2.0-3.0 USING THE INRATIO. THE PATIENT WASN'T FEELING WELL LATER THAT DAY, WENT TO THE ER THEN SUFFERED A STROKE. THE HOSPITAL INR RESULT WAS 1.7 WITH AN APPROXIMATE TIME AFTER THE FIRST INRATIO TEST OF 36 HOURS. ALTHOUGH REQUESTED, NO OTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873709 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO 100071 262184

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S