BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5061218 · Received September 8, 2015

    Report

    Report Number
    2027969-2015-00654
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 13, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION UPDATE: 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 357499 MEETS RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. ALTHOUGH A RELEVANT NC WAS NOTED IN THE BATCH RECORD, IT DID NOT AFFECT THE FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND ADDITIONAL CORRECTIVE ACTIONS WERE NOT REQUIRED. IT WAS REPORTED THAT THE CUSTOMER HAS ANEMIA. THEIR LAST HEMATOCRIT READING WAS BELOW 30%. THIS CONDITION MAY IMPACT THE PERFORMANCE OF THE ASSAY. ALTHOUGH IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT, A ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER CALLED ALLEGING DISCREPANT INRATIO VALUES. PATIENT'S THERAPEUTIC RANGE = 2.0 - 3.0. (B)(6) 2015 OTHER POC = 1.7. (B)(6) 2015 INRATIO = 4.1. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594305 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100071 357499

    Patients

    Seq Age Sex Outcome Treatment
    1