BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1001123 · Received February 15, 2008

    Report

    Report Number
    2954730-2008-00074
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    December 13, 2007
    Report Date
    February 15, 2008
    Manufacturer
    HEMOSENSE, SJ
    Product Code
    JPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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: >7.5, LAB: 1.2, MEAN: NA, CONFIDENCE LIMITS: CANNOT BE DETERMINED; INRATIO: 1.0, LAB: 1.2, MEAN: 1.1, CONFIDENCE LIMITS: 1.0-1.5. PER INTERNAL PROCEDURE, THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. FOR THE FIRST SET OF DATA, THE CONFIDENCE LIMITS CANNOT BE DETERMINED. FOR THE SECOND SET OF DATA, 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. PRODUCTS WILL BE TESTED. TS UPDATED THIS CASE IN 2008. PER TEST "QA ASKED FOR LOT# DURING COMPLAINT. TSR CALLED CUSTOMER, NO RECORD OF PAST LOT EXCEPT FOR PREVIOUS. DECEMBER RECORDS HAVE BEEN WIPED FROM MACHINE DUE TO VOLUME OF TESTS." CALLED DIDN'T HAVE ANY STRIPS LOT RECORD. INSUFFICIENT INFO AVAILABLE. NO FURTHER TESTING CAN BE PERFORMED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: 2007, INRATIO: >7.5, LAB: 1.2; INRATIO: 1.0, LAB: 1.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA HEMOSENSE, SJ KIT, PROFESSIONAL USER, ENGLISH

    Patients

    Seq Age Sex Outcome Treatment
    1