BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 872823 · Received June 26, 2007

    Report

    Report Number
    2954730-2007-00285
    Event Type
    Malfunction
    Date Received
    June 26, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 20, 2007
    Manufacturer
    HEMOSENSE, INC.
    Product Code
    JPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: 2007; INRATIO: 2.0; LAB: 2.2; MEAN:2.1; CONFIDENCE LIMITS: 1.4 -3.1. DATE: SAME DAY; INRATIO: 3.1; LAB: 3.1; MEAN:3.1; CONFIDENCE LIMITS: 1.9 -4.6. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. THE RESULTS ARE NOT CONSIDERED DISCREPANT WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. THEREFORE, FURTHER TESTING IS NOT REQUIRED AT THIS TIME. DUE TO THE FACT THAT THE CUSTOMER HAD BLOOD IN HIS URINE/STOOL AND HE WENT TO THE ER, AND WAS TESTED FOR PT/INR AND INR WAS VERY HIGH (NO ACTUAL NO OBTAINED) PER DEE, THIS QUALIFIES THIS CASE AS AN ADVERSE EVENT. ALSO PER TS UPDATE ON THE SAME DAY, PT WAS GIVEN 10MG OF VIT K, DC COUMADIN AND IV WAS GIVEN. PRODUCT WILL BE TESTED WHEN RETURNED.

    Description of Event or Problem · 1

    CALLER ALLEGES INACCURACY WITH INRATIO. RESULTS AS FOLLOWS: DATE: 2007; INRATIO: 2.0; LAB: 2.2. DATE: SAME DAY. INRATIO: 3.1; LAB: 3.1. DUE TO THE FACT THAT THE CUSTOMER HAD BLOOD IN HIS URINE/STOOL AND HE WENT TO THE ER, AND WAS TESTED FOR PT/INR AND INR WAS VERY HIGH (NO ACTUAL NO OBTAINED). THIS QUALIFIES THIS CASE AS AN ADVERSE EVENT. ALSO PER TS UPDATE ON THE NEXT DAY, PT WAS GIVEN 10 MG OF VIT K, DC COUMADIN AND IV WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, INC. 070195

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R