BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1553953 · Received November 10, 2009

    Report

    Report Number
    2027969-2009-01057
    Event Type
    Malfunction
    Date Received
    November 10, 2009
    Date of Event
    October 22, 2009
    Report Date
    November 10, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    JPA
    PMA / PMN Number
    021923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INRATIO PRECISION DATA PROVIDED BY END-USER LOT: DATE: (B)(6) 2009; CUSTOMER'S INRATIO = 4.30 INR; DOCTOR'S INRATIO = 3.50 INR; MEAN = 3.90 INR; SD = 0.57; %CV = 14.50. SINCE 14.50% CV IS LESS THAN 20%, INRATIO METER RESULTS PASS THE CRITERIA FOR PRECISION. NO FURTHER TESTING IS REQUIRED AT THIS TIME. CV% CALCULATION FROM COMPARISON TEST DATA PROVIDED BY END-USER REVEALED PRECISION CRITERIA HAD BEEN MET. PRODUCT DEFICIENCY WAS NOT ESTABLISHED. NO PRODUCT IS EXPECTED TO BE RETURNED. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. AS OF 11/04/2009, 26 DISCREPANT RESULT COMPLAINTS WERE REPORTED FOR LOT #214530 YIELDING A COMPLAINT RATE OF 0.043%. 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. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME 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: 4.3; LAB: 3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE INCORPORATED 100071 214530

    Patients

    Seq Age Sex Outcome Treatment
    1