BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3912365 · Received May 13, 2014

    Report

    Report Number
    2027969-2014-00436
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 6, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. 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. THE CUSTOMER WAS ON LOVENOX FROM (B)(6) 2014. LIMITATIONS IN PACKAGE INSERT: "THIS TEST SHOULD NOT BE USED FOR PATIENTS ON HEPARIN THERAPY." THIS CONSTITUTES OFF-LABEL USE AND CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE UNEXPECTED RESULTS. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE NON-CONFORMANCE ASSOCIATED WITH THIS LOT WAS NOT RELEVANT TO THE INITIAL COMPLAINT AND DOES NOT AFFECT PRODUCT PERFORMANCE. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF THE PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    "CALLER ALLEGED DISCREPANT RESULTED COMPARED WITH THE REFERENCE. RESULTS AS FOLLOWS:" WARFARIN, HELD (B)(6). RESUMED NORMAL UNSPECIFIED DOSE (B)(6). LOVENOX (B)(6); IRON SUPPLEMENT, DOSE DOUBLED ON (B)(6)- EXACT DOSE NOT PROVIDED. PATIENT HOSPITALIZED (B)(6) FOR HERNIA SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285714 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 332831

    Patients

    Seq Age Sex Outcome Treatment
    1 MONITOR SERIAL #: (B)(4)| WARFARIN,| VITAMIN B12, NO RECENT CHANGES.