BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO

    MDR report key: 1603551 · Received February 2, 2010

    Report

    Report Number
    2027969-2010-00125
    Event Type
    Injury
    Date Received
    February 2, 2010
    Date of Event
    January 4, 2010
    Report Date
    February 2, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: (B) (6) 2010, INRATIO METER= 2.5 INR. REFERENCE= 12 INR. MEAN= 7.70. CONFIDENCE LIMITS= UNABLE TO DETERMINE. DATE: (B) (6) 2010. INRATIO METER= 3.2 INR. REFERENCE= 16.9. MEAN=10.05, CONFIDENCE LIMITS= UNABLE TO DETERMINE. THE MEAN IS >5.0 AND THE DIFFERENCE IS GREATER THAN 2.2. THESE RESULTS ARE CONSIDERED INACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. ADDITIONAL INVESTIGATION IS REQUIRED. PATIENT'S HCT LEVEL WAS 24.9% AND COULD AFFECT INRATIO TEST RESULT. IT IS RECOMMENDED INRATIO METER USED ONLY WITH PATIENT'S HEMATOCRIT RANGES BETWEEN 30-55% IN PRODUCT USER GUIDE. REPLICATION TESTING WITH RETURNED METER AND THERAPEUTIC SAMPLE DID NOT REPRODUCE COMPLAINT. METER FUNCTIONAL TEST WAS PERFORMED AND METER DEFICIENCY WAS NOT ESTABLISHED. AS OF (B) (6) 2010, 1 DISCREPANT RESULT COMPLAINT WAS REPORTED FOR LOT #222164 YIELDING A COMPLAINT RATE OF 0.006%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (>0.07%) NO FURTHER ACTION IS REQUIRED AT THIS TIME. ON GOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 222164

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention