BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5626465 · Received May 3, 2016

    Report

    Report Number
    2027969-2016-00290
    Event Type
    Malfunction
    Date Received
    May 3, 2016
    Date of Event
    March 1, 2016
    Report Date
    April 12, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENT IS ESTIMATED AS (B)(6) 2016 AS IT WAS REPORTED THE EVENT OCCURRED IN THE LAST 4 WEEKS PRIOR TO THE REPORTED EVENT ON (B)(6) 2016. INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K382423 MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. A 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.

    Additional Manufacturer Narrative · 1

    CORRECTION: ADDITIONAL MFR NARRATIVE SHOULD REMOVE "A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER" AND STATE "NO PROBLEM WAS FOUND."

    Description of Event or Problem · 1

    THE FOLLOWING VARIANCE BETWEEN THE INRATIO INR RESULT AND THE LABORATORY INR RESULT WAS REPORTED VIA TELEPHONE CALL ON (B)(6) 2016 ON A PATIENT IN (B)(6). THE EVENT OCCURRED IN THE PRIOR FOUR (4) WEEKS TO REPORT BUT THE EXACT DATE WAS UNKNOWN. RESULTS ARE AS FOLLOWS: INRATIO2 INR: 2.0, LABORATORY INR: 1.62. THE TIME BETWEEN ALL TESTING AND 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
    284206 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K382423

    Patients

    Seq Age Sex Outcome Treatment
    1