BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5573661 · Received April 13, 2016

    Report

    Report Number
    2027969-2016-00224
    Event Type
    Malfunction
    Date Received
    April 13, 2016
    Date of Event
    March 22, 2016
    Report Date
    March 23, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, THERAPEUTIC DONOR TESTING WAS PERFORMED WITH RETAINED STRIPS OF LOT K382947. IN-HOUSE TESTING OF STRIP LOT K382947 MET ACCURACY CRITERIA AND NO PRODUCT DEFICIENCY WAS OBSERVED. 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. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A VARIANCE BETWEEN TWO (2) INRATIO2 INR RESULTS WAS REPORTED ON A PATIENT IN (B)(6). RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2016, INRATIO2 INR: (17:10) 2.1 AND (17:13) 4.4. THE FIRST RESULT DID OT SEEM PLAUSIBLE THEREFORE A SECOND TEST WAS PERFORMED. THE THERAPEUTIC RANGE WAS 3.0 - 3.5 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
    229811 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K382947

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO MONITOR SN (B)(4)