BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5108328 · Received September 28, 2015

    Report

    Report Number
    2027969-2015-00707
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 9, 2015
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF THE ENTIRE IN-HOUSE TESTING HISTORY OF THE LOT WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 365429A WAS FOUND TO BE PERFORMING WITHIN EXPECTATIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. IT WAS REPORTED THAT THE CUSTOMER HAS RHEUMATOID ARTHRITIS AND ANEMIA. THESE CONDITIONS MAY IMPACT THE PERFORMANCE OF THE ASSAY. THE TECHNIQUE ISSUE IDENTIFIED IN THE COMPLAINT MAY HAVE CONTRIBUTED TO THE UNEXPECTED RESULTS EXPERIENCED 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. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2015, INRATIO INR: 3.9 AND 1.4. THERAPEUTIC RANGE: 2.0 - 3.0. THE TIME BETWEEN TESTING WAS FIVE (5) MINUTES. THE CUSTOMER REPORTED THAT THE FINGER WAS "MILKED" WHEN THE 3.9 RESULT WAS OBTAINED. THIS IS CONSIDERED TO BE AN IMPROPER TECHNIQUE WHEN PERFORMING THE INRATIO TEST. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638872 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 365429A

    Patients

    Seq Age Sex Outcome Treatment
    1