BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 1439024 · Received May 5, 2009

    Report

    Report Number
    2027969-2009-00291
    Event Type
    Malfunction
    Date Received
    May 5, 2009
    Date of Event
    April 7, 2009
    Report Date
    May 5, 2009
    Manufacturer
    BIOSITE, INC.
    Product Code
    JPA
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    QC ERRORS ARE DESIGNED TO BE GENERATED IF THE STRIP HAS BEEN EXPOSED TO ADVERSE ENVIRONMENTAL CONDITION. THERE IS NO INFORMATION IN THE COMPLAINT TO INDICATED STRIP EXPOSURE. THESE ERRORS ALSO ARISE IF THERE IS A SAMPLING OR TECHNIQUE PROBLEM. INRATIO PRECISION DATA PROVIDED BY END-USER: FIRST TEST INR = 4.4, SECOND TEST INR =2.9, MEAN = 3.65; SD = 1.06; %CV = 29.1%. THE %CV IS GREATER THAN 20%. THE PRECISION CRITERION IS NOT MET. PRODUCT TESTING IS REQUIRED. VALUES FROM PREVIOUS PRECISION TESTING (2009) ON TWO THERAPEUTIC DONORS WITH STRIP LOT NUMBER 080584A MEET THE CRITERION FOR PRECISION. NO FURTHER TESTING IS REQUIRED. CERTAIN PRESCRIPTION DRUGS AND OVER-THE-COUNTER MEDICATIONS (E.G., ANTIBIOTICS) CAN AFFECT THE ACTION OF ORAL ANTICOAGULANTS AND THE INR VALUE. ERROR AND UNEXPECTED RESULT MAY HAVE BEEN CAUSED BY USER TECHNIQUE AND/OR PATIENT'S THERAPY. THIS FAILURE MODE WILL CONTINUE TO BE MONITORED TO DETERMINE IF FUTURE CORRECTIVE ACTION IS WARRANTED. THERE HAVE BEEN 24 DISCREPANT RESULTS COMPLAINTS REPORT FOR LOT # 080584 YIELDING A COMPLAINT RATE OF 0.005% 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. DEVICE WAS NOT RETURNED FOR EVALUATION. INVESTIGATION IS CLOSED. NO CORRECTIVE ACTION IS REQUIRED AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS WITH INRATIO READINGS. RESULTS ARE AS FOLLOWS: PATIENT'S INR WAS 4.4 THE FIRST TIME, RETESTED AND WAS 2.9. THE THIRD TIME, USER RECEIVED AN ERROR (QC2H). NURSE USED THE SAME FINGER FOR THE 2ND TEST. PATIENT HAD AN INJECTION OF ANTIBIOTICS SEVERAL DAYS AGO WHICH MIGHT INTERFERE WITH HER INR READING. HER INR IS OUT OF HER TARGET RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO PROTHROMBIN TIME TEST JPA BIOSITE, INC. 0100139

    Patients

    Seq Age Sex Outcome Treatment
    1 NI