BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4110173 · Received September 11, 2014

    Report

    Report Number
    2027969-2014-00837
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND STRIP REPEATABILITY CRITERIA. A REVIEW OF THE MANUFACTURER RECORD FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCE. LOT MEETS RELEASE SPECIFICATION. ALTHOUGH THE ROOT CAUSE ANALYSIS DID NOT INCLUDE RETURN TESTING, OFF-LABEL USE WAS IDENTIFIED AND CANNOT BE RULED OUT AS A CAUSE FOR THE ERROR EXPERIENCED 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 RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(4)2014, INRATIO: 2.6, LAB: 1.6. TIME BETWEEN TESTING: UNKNOWN. THERAPEUTIC RANGE: 2.0 - 4.0. PATIENT SELF TESTER IS AN (B)(6) OLD POST CARDIAC SURGERY PATIENT. PORT SAMPLE WAS USED WHEN TESTING THE INRATIO TEST. PATIENT SELF TESTER'S MOTHER, (B)(4) WAS ADVISED THAT INRATIO MONITOR IS VALIDATED ONLY FOR FINGER STICK WHOLE BLOOD AND NOT FOR VENOUS SAMPLE. THE PRODUCT IS FOR USE ON PATIENT'S 18 YEARS AND OLDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562382 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 333863

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR WARFARIN| LIST OF MEDICATIONS NOT PROVIDED, BUT NO CHANGES| AT THIS TIME| HEPARIN FLUSH IN LINES