BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIP

    MDR report key: 3853726 · Received April 10, 2014

    Report

    Report Number
    2027969-2014-00318
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    February 25, 2014
    Report Date
    March 28, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE CUSTOMER REPORTED A PRECISION ISSUE DURING TESTING ON THEIR INRATIO METER. THE CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADDITIONAL INFORMATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, AND A LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORD REVIEW WAS NOT PERFORMED AND 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

    CALLER ALLEGED DISCREPANT INRATIO INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO INR: 4.5 AND 1.3. THE TIME BETWEEN TESTING AND THE PATIENT'S THERAPEUTIC RANGE WAS NOT PROVIDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELAE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218492 INRATIO PT/INR TEST STRIP PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G2

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO METER, SN: UNKNOWN