BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5563160 · Received April 8, 2016

    Report

    Report Number
    2027969-2016-00209
    Event Type
    Malfunction
    Date Received
    April 8, 2016
    Date of Event
    March 14, 2016
    Report Date
    March 14, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INRATIO2 PT/INR TEST STRIPS 99008G1, LOT# K382423 REFERENCED IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT 2027969-2016-00208. INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING. IN-HOUSE TESTING ON STRIP LOTS K382423 AND K384107 MET RELEASE CRITERIA AND NO LOT TO LOT BIAS WAS OBSERVED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. A ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A PHYSICIAN'S OFFICE IN (B)(6) REPORTED LOT TO LOT VARIABILITY ON THE INRATIO2 TESTING STRIPS. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2016, INRATIO2 INR STRIP LOT# K382423:2.9 AND 6.3, INRATIO2 INR STRIP LOT # K384107: 7.3. THE FIRST TWO (2) ATTEMPTS, TO OBTAIN AN INR, ON STRIP LOT# K382423 RESULTED IN ERROR MESSAGES. TESTING WAS PERFORMED CONSECUTIVELY. THE THERAPEUTIC RANGE WAS UNKNOWN. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS ABLE TO BE PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220665 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K384107

    Patients

    Seq Age Sex Outcome Treatment
    1