BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5110912 · Received September 29, 2015

    Report

    Report Number
    2027969-2015-00712
    Event Type
    Malfunction
    Date Received
    September 29, 2015
    Date of Event
    August 27, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: 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 369157A MEETS RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT # 369157A DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATIONS. ALTHOUGH AN IMPROPER TECHNIQUE AND USER ISSUE WERE IDENTIFIED IN THE COMPLAINT, A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT SELF TESTER ALLEGING DISCREPANT INRATIO VALUE. PATIENT'S THERAPEUTIC RANGE 2-3. (B)(6) 2015 INRATIO = 6.5; (B)(6) 2015 DR'S POC = 4.0. COUMADIN HELD ON (B)(6) 2015. ON (B)(6) 2015, PATIENT RESUMED COUMADIN. (B)(6) 2015 PATIENT SELF TESTER VISITED THE DOCTOR AND RECEIVED AN INR OF 1.5 USING THE DOCTOR'S METER. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642064 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 369157A

    Patients

    Seq Age Sex Outcome Treatment
    1