BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1621430 · Received February 17, 2010

    Report

    Report Number
    2027969-2010-00189
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 28, 2010
    Report Date
    February 17, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    K021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT RHE TIME COMPLAINT WAS FILED: DATE: (B) (6) 2010; INRATIO: 2.0; REFERENCE: 2.8; MEAN: 2.4; CONFIDENCE LIMITS: 1.4-3.4. THREE HOURS LAPSE BETWEEN TWO READINGS. DATE: (B) (6) 2010; INRATIO: 1.5; REFERENCE: 2.8; MEAN: 2.15; CONFIDENCE LIMITS: 1.4-3.1. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE 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. CONCLUSION: DATA ANALYSIS OF MEAN CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED BOTH INRATIO AND LAB VALUES ARE WITHIN THE CONFIDENCE LIMITS FOR INR TESTING. TROUBLE SHOOT INVESTIGATION REVEALED SAMPLE SIZE MAY BE SMALLER THAN REQUIRED. IT COULD CONTRIBUTE TO INR TEST DISCREPANCY. AS OF 02/16/2010, FOURTEEN DISCREPANT RESULTS COMPLAINTS WERE REPORTED FOR LOT #220375 YIELDING A COMPLAINT RATE OF 0.003%. DUE TO THIS LOW OCCURRENCE RATE, BELOW THE ACTION THRESHOLDS MONITORED BY QA FOR CORRECTIVE ACTION (GREATER THAN 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.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B) (6) 2010; INRATIO: 2.0; LAB: 2.8. (B) (6) 2010; 1.5; 2.8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100139 220375

    Patients

    Seq Age Sex Outcome Treatment
    1