BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4173062 · Received October 9, 2014

    Report

    Report Number
    2027969-2014-00922
    Event Type
    Malfunction
    Date Received
    October 9, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING DATA WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. A REVIEW OF THE MANUFACTURER RECORD FOR THE LOT DID NOT UNCOVER ANY NON-CONFORMANCE. LOT MEETS RELEASE SPECIFICATION. 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. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: DATE (B)(6) 2014, INRATIO: 2.3, LAB GREATER THAN 20 (X2). TIME BETWEEN TESTS: UNK. THERAPEUTIC RANGE: UNK. MR. (B)(6) WAS TO CALL BACK ON BEHALF OF THE PATIENT SELF TESTER AS INFORMATION BECOME AVAILABLE. TECHNICAL SERVICES WAS NOT ABLE TO REACH THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637065 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 349906

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SERIAL NUMBER: (B)(4)