BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 4962073 · Received August 3, 2015

    Report

    Report Number
    2027969-2015-00559
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 12, 2015
    Report Date
    July 13, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION:AS OF 10/19/2015, NO PRODUCT WAS RETURNED FOR EVALUATION. THEREFORE, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE STRIP TESTING ON THE REPORTED STRIP LOT HAD MET CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS.IT WAS REPORTED THAT THE CUSTOMER HAS OSTEOARTHRITIS. THIS CONDITION MAY IMPACT THE PERFORMANCE OF THE ASSAY. THE 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 AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CALLER ALLEGED A VARIANCE BETWEEN THE INRATIO INR RESULTS AND THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, INRATIO INR: 4.0 AND 3.8, LABORATORY INR: 2.4. THERAPEUTIC RANGE: 2.5 - 3.5. THE TIME BETWEEN THE INITIAL INRATIO TEST AND THE LABORATORY TEST WAS FOUR (4) HOURS. THE TIME BETWEEN THE LABORATORY TEST AND THE REPEAT INRATIO TEST WAS THREE (3 HOURS). THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2015 FOR CHEST PAINS AND DIAGNOSED WITH UNSPECIFIED CHEST PAIN. THE PATIENT WAS TREATED WITH TRAMADOL AND SENT HOME. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505279 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 354357

    Patients

    Seq Age Sex Outcome Treatment
    1