BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6091529 · Received November 9, 2016

    Report

    Report Number
    2027969-2016-00676
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 11, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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 393630A WAS PERFORMED. IN-HOUSE TESTING ON THE STRIP LOT MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. AN IMPROPER TECHNIQUE AND A CONDITION THAT MAY IMPACT THE PERFORMANCE OF THE ASSAY 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 PATIENT REPORTED THE FOLLOWING DISCREPANT HIGH INRATIO INR RESULTS AS COMPARED TO A LABORATORY METHOD: (B)(6) 2016: INRATIO INR RESULTS= 5.8 AND 4.2. TESTS CONDUCTED MINUTES APART; (B)(6) 2016: LABORATORY INR RESULT= 3.7. THERAPEUTIC RANGE: 3.0-4.0. THE PATIENT REPORTED THE MONITOR WAS NOT IN CORRECT MODE WHEN FINGERSTICK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741379 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 393630A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR INRATIO2 PT MONITOR, PN 200432, SERIAL# (B)(4)