BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR STRIPS

    MDR report key: 5645657 · Received May 10, 2016

    Report

    Report Number
    2027969-2016-00306
    Event Type
    Injury
    Date Received
    May 10, 2016
    Date of Event
    April 13, 2016
    Report Date
    May 11, 2016
    Manufacturer
    DRES. FREILINGER & PARTNER
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K383465 MEETS RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MET RELEASE SPECIFICATIONS. IT WAS REPORTED THAT THE CUSTOMER HAS RHEUMATIC DISEASES. THESE CONDITIONS MAY IMPACT THE PERFORMANCE OF THE ASSAY. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. CAPA-(B)(4) WAS INITIATED TO INVESTIGATE HIGHLY DISCREPANT RESULTS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    A REPORT OF DISCREPANT INRATIO RESULTS WAS RECEIVED ON (B)(6) 2016. RESULTS AS FOLLOWS: (B)(6). CALLER REPORTS THAT THE PATIENT HAD VARIOUS ERROR CODES FROM THE BEGINNING; THE SPECIFIC ERROR CODES ARE UNKNOWN. THE PATIENT WENT TO THEIR PHYSICIAN'S OFFICE ON (B)(6) 2016 WITH VARIOUS BRUISES. THE LAB RESULT ON (B)(6) 2016 WAS 6.5; THE PATIENT WAS GIVEN VITAMIN K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298547 INRATIO PT/INR STRIPS PROTHROMBIN TIME TEST GJS DRES. FREILINGER & PARTNER 99008G1 K383465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention