BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5065941 · Received September 9, 2015

    Report

    Report Number
    2027969-2015-00659
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 11, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF ALL IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE TESTING ON RETAINED STRIP LOT K362392 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 HAD A RESPIRATORY TRACT INFECTION. THIS CONDITION MAY IMPACT THE PERFORMANCE OF THE ASSAY. 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6). CALLER ALLEGING DISCREPANT INRATIO VALUES. PATIENT'S THERAPEUTIC RANGE: 2 - 3. (B)(6) 2015 INRATIO = 1.4; LAB = 2.1 30 MINUTES BETWEEN TESTS. NO REPORTED PATIENT AE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595321 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HSO99008G1 K362392

    Patients

    Seq Age Sex Outcome Treatment
    1