BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6042568 · Received October 19, 2016

    Report

    Report Number
    2027969-2016-00660
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE IN-HOUSE TESTING HISTORY OF STRIP LOT 387626A WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED WHEN IT WAS WITHIN EXPIRATION. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. AN IMPROPER TECHNIQUE WAS IDENTIFIED IN THE COMPLAINT. THIS COULD NOT BE RULED OUT AS A CAUSE FOR THE COMPLAINT. 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 CUSTOMER REPORTED A VARIANCE BETWEEN THE INRATIO INR RESULT OF 1.4 AND THE LABORATORY INR RESULT OF 2.3. THERAPEUTIC RANGE: UNKNOWN. THE CUSTOMER REPORTED MILKING THE PATIENT'S FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690994 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 387626A

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO2 PT MONITOR, PN 200431, SERIAL# (B)(4)