BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIOR PT/INR TEST STRIP

    MDR report key: 3813535 · Received March 26, 2014

    Report

    Report Number
    2027969-2014-00273
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 19, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. THEREFORE, INVESTIGATION OS 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 FOR THE REPORTED LOT NUMBER. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCTS PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE CUSTOMER WAS ON LOVENOX DURING TESTING. THIS TEST SHOULD NOT BE USED FOR PT'S ON HEPARIN THERAPY. THIS CONSTITUTES OFF-LABEL USE AND CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE UNEXPECTED RESULTS. ADDITIONALLY, IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT AND MAY HAVE CONTRIBUTED TO THE UNEXPECTED RESULTS. THE MFG RECORDS FOR THE LOT WERE REVIEWED. THE LOT MET SPECIFICATIONS AND NO NON-CONFORMANCES WERE DOCUMENTED. NO FURTHER INVESTIGATION WILL BE PURSED AT THIS TIME. BASED ON THE INFO 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 LOW INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014, INRATIO2 INR: 1.6, LABORATORY INR: 2.2. THE TIME BETWEEN TESTING WAS WITHIN FORTY (40) MINUTES. REPORTEDLY, MULTIPLE FINGER STICKS WERE PERFORMED ON THE SAME FINGER. ADDITIONALLY, THE PT HAD AN INJECTION OF LOVENOX ON (B)(6) 2014. THERE WAS NO REPORTED ADVERSE OT SEQUELA. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176902 INRATIOR PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC 99008G2 328705

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN,| INRATIO2 PT/INR PRO MONITOR: (B)(4)| VERAPAMIL,| LAST INJECTION:| LOVENOX,| METOPROLOL,