BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 4909696 · Received July 13, 2015

    Report

    Report Number
    2027969-2015-00508
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    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

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    THE TRAINING CENTER INRATIO2 INR RESULT WAS REPORTED AS A 1.4 AND SHOULD HAVE BEEN 1.5. INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, IN-HOUSE TESTING WAS PERFORMED ON THE REPORTED LOT NUMBER. THE RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED DURING IN-HOUSE INVESTIGATION. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. 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 FOLLOWING VARIANCE WAS REPORTED BY THE INRATIO TRAINING CENTER IN (B)(6) ON A PATIENT IN SELF MANAGEMENT. DATE: 06/16/2015, INRATIO2 INR: 4.2 (LOT# K366051), TRAINING CENTER INRATIO2 INR: 1.4 (LOT# K370018), ALTERNATE POINT OF CARE (POC) INR: 1.5. THE TIME BETWEEN TESTING WAS WITHIN MINUTES. THE PATIENT'S THERAPEUTIC RANGE WAS NOT PROVIDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE TRAINING CENTER INRATIO2 INR FOR LOT # K370018 WAS A 1.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453230 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K366051

    Patients

    Seq Age Sex Outcome Treatment
    1