BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CINRATIO PT/INR TEST STRIPS

    MDR report key: 4121352 · Received September 19, 2014

    Report

    Report Number
    2027969-2014-00858
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 25, 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
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: SEE SCANNED TABLE. TESTS PERFORMED SIDE BY SIDE ON (B)(6) 2014. THERAPEUTIC RANGE: 2.0-3.0. THE CUSTOMER SENT THE PATIENT TO THE HOSPITAL FOR CONFIRMATORY TESTING AFTER THE LAB RESULT ON (B)(6) 2014. THE PATIENT BELIEVED THAT THERE WAS AN ERROR IN THE LAB READING BECAUSE HE HAD NO UNUSUAL BRUISING OR BLEEDING. THE PATIENT TOLD THE FACILITY THAT HE HAD AN ABRASION ON (B)(6) 2014 THAT STOPPED BLEEDING ALMOST IMMEDIATELY; HE DID NOT FEEL THIS MATCHED WITH THE HIGH LAB INR VALUES. AFTER RECEIVING THE LAB RESULT ON (B)(6) 2014, THE PATIENT WAS ADMINISTERED VITAMIN K AT (B)(6) AND SENT HOME. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583758 CINRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 345310

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention ALLOPURINOL 100MG/DAY| CYCLOBENZAPRINE 10MG 1-3X/DAY AS NEEDED.| INRATIO MONITOR, SERIAL # (B)(4)| LAB IS USING SIEMENS CA1500 INNOVEN REAGENTS| LISINOPRILL 10MG/DAY| WARFARIN SODIUM| LISINOPRILL 10MG/DAY| ALLOPURINOL 100MG/DAY| INRATIO MONITOR, SERIAL # (B)(4)| WARFARIN SODIUM| LAB IS USING SIEMENS CA1500 INNOVEN REAGENTS| CYCLOBENZAPRINE 10MG 1-3X/DAY AS NEEDED.