BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1556659 · Received November 19, 2009

    Report

    Report Number
    2027969-2009-01076
    Event Type
    Malfunction
    Date Received
    November 19, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 19, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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: DATE: (B) (6) 2009; INRATIO METER: 4.9 INR; REFERENCE: 7.0 INR; MEAN: 5.95; CONFIDENCE-LIMITS: UNABLE TO DETERMINE. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. THE MEAN IS >5.0 AND THE DIFFERENCE IS LESS THAN 2.2. AND ONLY ONE INR VALUE IS GREATER THAN 5.0. THESE RESULTS ARE CONSIDERED ACCURATE WITHIN THE CONTEXT OF THE DOCUMENTED VARIABILITY FOR INR TESTING. CUSTOMER RESULTS ANALYZED AND THE RESULTS ARE BEYOND THE CONFIDENCE LIMITS DETERMINE RANGE, BUT THE DIFFERENCE BETWEEN THE RESULTS WAS LESS THAN 2.2 WHICH IS CONSIDERED ACCURATE. NO DISCREPANCY WAS ESTABLISHED. NO FURTHER ACTION REQUIRED. AS OF 11/12/2009, 8 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #220408 YIELDING A COMPLAINT RATE OF 0.002%. 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. ONGOING TRENDING SHALL BE PERFORMED TO DETERMINE IF FURTHER ACTION IS WARRANTED. CORRECTIVE ACTION NOT REQUIRED AS PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2009; INRATIO: 4.9; LAB: 7.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220408

    Patients

    Seq Age Sex Outcome Treatment
    1