BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1573886 · Received December 21, 2009

    Report

    Report Number
    2027969-2009-01193
    Event Type
    Malfunction
    Date Received
    December 21, 2009
    Date of Event
    November 25, 2009
    Report Date
    December 21, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    GJS
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: INRATIO: 1.5, REFERENCE: 2.3, MEAN: 1.90, CONFIDENCE LIMITS: 1.3-2.7. MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED 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. METER AND STRIPS WERE NOT EXPECTED TO BE RETURNED. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. TREND ANALYSIS IS NOT REQUIRED, BECAUSE STRIP LOT #080731 IS NOW EXPIRED. (EXPIRATION DATE: LAST DAY OF NOV. 2009). NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2009, INRATIO: 2.3, LAB: 1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST GJS BIOSITE INCORPORATED 100139 080731A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI