BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIP

    MDR report key: 3853840 · Received April 18, 2014

    Report

    Report Number
    2027969-2014-00359
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 2, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED DISCREPANT LOW INRATIO INR RESULTS DURING TESTING. THE CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADDITIONAL INFORMATION. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. MANUFACTURING RECORD REVIEW WAS NOT PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED. FURTHER INVESTIGATION WAS NOT POSSIBLE. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). CALLER ALLEGING RECEIVING DISCREPANT INRATIO2 RESULTS. ON (B)(6) 2014: LAB: 2.6, INRATIO2: 1.3. ON (B)(6) 2014: LAB: 2.6, INRATIO2: 1.4. TIME BETWEEN LAB AND INRATIO TESTING LESS THAN 30 MINUTES. PATIENT'S THERAPEUTIC RANGE 2-3. CUSTOMER DID NOT PROVIDE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238700 INRATIO2 PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HSO99008EU

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR: SN UNK| AUGMENTIN FINAL DOSE| CLEXANE 80MG FINAL DOSE