BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3060907 · Received April 10, 2013

    Report

    Report Number
    2027969-2013-00283
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 7, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATA ANALYSIS PERFORMED ON INR RESULTS PROVIDED BY CUSTOMER. REVIEWED RETAIN TESTING ON REPORTED LOT 274167. OBSERVATIONS DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH LAB RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: DATE: (B)(6) 2013, INRATIO METER = 4.6 INR, REFERENCE = 5.8 INR, MEAN = 5.20. 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. IN-HOUSE THERAPEUTIC DONOR TESTING HAS BEEN PERFORMED ON REPORTED LOT 274167 ON (B)(4) 2013. RESULTS AS FOLLOWS: (B)(4). ALL REPLICATES FOR EACH DONOR ARE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN (B)(4). ACCURACY AND PRECISION CRITERIA HAVE BEEN MET. NO FURTHER INVESTIGATION IS NECESSARY. CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCREPANT RESULTS COMPARED TO LAB RESULTS ARE AS FOLLOWS: DATE (B)(6) 2013, INRATIO: 4.6, LAB: 5.8. PATIENT'S THERAPEUTIC RANGE: 2-3. TIME BETWEEN EACH METHOD OF TESTING: 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148515 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC. 100139 274167

    Patients

    Seq Age Sex Outcome Treatment
    1 ONLY DIABETES TREATMENT| COUMADIN