BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5621556 · Received April 29, 2016

    Report

    Report Number
    2027969-2016-00282
    Event Type
    Malfunction
    Date Received
    April 29, 2016
    Date of Event
    March 23, 2016
    Report Date
    April 4, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. RETAIN STRIPS TESTED ON THE RETURNED MONITOR MET EXPECTATIONS. ADDITIONALLY, THE RETURNED MONITOR MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING INVESTIGATION. ALTHOUGH THE CUSTOMER'S COMPLAINT WAS REPLICATED AND DISCREPANT RESULTS WERE OBSERVED DURING THE INVESTIGATION, THE SYSTEM IS PERFORMING WITHIN EXPECTATIONS. A REVIEW OF THE LOT TESTING HISTORY FOR LOT K381677 WAS PERFORMED. THE LOT MET EXPECTATIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. IMPEDANCE CURVE ANALYSIS WAS UNABLE TO BE PERFORMED BECAUSE THE CUSTOMER'S COMPLAINT VALUE WAS NOT ONE OF THE FOUR MOST RECENT RESULTS. THE INRATIO MONITOR IS ONLY CAPABLE OF RETAINING THE MOST RECENT FOUR IMPEDANCE CURVES. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    A VARIANCE BETWEEN INRATIO INR RESULT AND LAB INR RESULT WAS REPORTED. THE RESULTS WERE AS FOLLOWS: (B)(6) 2016 INRATIO INR=6.0; LAB INR=3.5. REPORTED THERAPEUTIC RANGE: 3.0-3.5. NOTE: THE INRATIO2 PRODUCT HS99008G1 IS NOT AVAILABLE IN THE UNITED STATES; HOWEVER, THIS MDR FILING IS DUE TO A SAME OR SIMILAR DEVICE BEING AVAILABLE IN THE UNITED STATES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276462 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS99008G1 K381677

    Patients

    Seq Age Sex Outcome Treatment
    1