BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 3946313 · Received July 9, 2014

    Report

    Report Number
    2027969-2014-00643
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE PATIENT WAS REPORTED AS USING HEPARIN. LIMITATIONS IN PRODUCT 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. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. 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

    CALLER ALLEGED DISCREPANT INRATIO RESULTS. RESULTS AS FOLLOWS: INRATIO: 5.3, LAB: 1.3. INRATIO2 READING WAS TAKEN AROUND 8:30AM AND LAB READING WAS TAKEN AROUND 10AM. THERAPEUTIC RANGE: 2.0-3.0. DUE TO THE INR READING FROM THE LAB, THE LOVENOX DOSAGE WILL CONTINUE UNTIL THE DOCTOR INSTRUCTS OTHERWISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399206 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 334472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MEDICATIONS: LOVENOX ((B)(6))| INRATIO MONITOR (B)(4)| XIFAXAN (LAST DOSE (B)(6))| MEDICATIONS: COUMADIN (STOPPED (B)(6))