BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5061989 · Received September 8, 2015

    Report

    Report Number
    2027969-2015-00639
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 11, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K370018 MET RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT K370018 DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. 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

    THE CALLER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULTS. ON (B)(6) 2015, THE PATIENT TESTED ON THE INRATIO DEVICE AND RECEIVED A 1.1 INR RESULT. THE PATIENT'S THERAPEUTIC RANGE WAS 2.5 - 3.5. WARFARIN WAS INCREASED THAT DAY TO 15MG AND LOVENOX 10MG WAS GIVEN. SEVEN (7) HOURS LATER ON (B)(6) 2015, THE INRATIO INR WAS 6.5., SIX (6) HOURS LATER THE INRATION INR WAS 2.3 AND <5 MINUTES APART THE INRATIO WAS 3.7. REPORTEDLY, THE FINGER TOUCHED THE TEST STRIP ON ONE OF THE TEST, HOWEVER, THE CALLER WAS UNABLE TO RECALL WHICH TEST CORRELATES TO THE TOUCHING OF THE TEST STRIP. THIS IS CONSIDERED TO BE AN IMPROPER TECHNIQUE WHEN PERFORMING THE INRATIO TEST. THE WARFARIN WAS HELD ON (B)(6) 2015 AND LOVENOX 10 MG WAS GIVEN. IT IS UNKNOWN AT WHAT POINT IN THE TESTING ON (B)(6) 2015, THE LOVENOX WAS GIVEN. UPON ASD FOLLOW-UP ON 09/02/2015, IT WAS DISCOVERED THAT ON (B)(6) 2015, THE PATIENT'S INRATIO INR WAS 2.4. ON (B)(6) 2015, THE PATIENT'S INRATIO INR WAS 1.5. IT IS UNKNOWN IF ANY WARFARIN ADJUSTMENT WAS MADE OR IF ANY LOVENOX WAS ADMINISTERED ON EITHER DATE. ON (B)(6) 2015, THE PATIENT WAS HOSPITALIZED IN ICU FOR INTERNAL BLEEDING AND AN INR OF 10.0. THE PATIENT WAS TREATED WITH ORAL VITAMIN K AND 2 UNITS OF FRESH FROZEN PLASMA (FFP). ON (B)(6) 2015, THE INR WAS 1.9. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592586 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R