BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 5022050 · Received August 21, 2015

    Report

    Report Number
    2027969-2015-00610
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 27, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION UPDATE: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE RELEASE SPECIFICATION IS WITHIN THE CALCULATED CONFIDENCE INTERVAL OF THE PERCENT FLIER RATE FOR COMPLAINT INVESTIGATION TESTING. NO PRODUCT DEFICIENCY WAS FOUND FOR LOT K363299. ALTHOUGH A RELEVANT NC WAS NOTED IN 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. 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.

    Description of Event or Problem · 1

    CALLER ALLEGING DISCREPANT INRATIO VALUES. EVENT OCCURRED IN (B)(6). (B)(6) 2015 INRATIO = 4.3 ; LAB = 2.5; FOUR HOURS BETWEEN INRATIO TEST AND LAB. (B)(6) 2015 INRATIO = 4.9; REPEAT INRATIO = 5.4; TIME BETWEEN TESTS UNKNOWN. PATIENT'S THERAPEUTIC RANGE: 2-3. PATIENT REPORTED HAVING AN OPERATION THREE WEEKS PRIOR AND RECENTLY SUFFERED FROM THE FLU. NATURE OF OPERATION AND DATES OF HOSPITALIZATION UNDISCLOSED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555247 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. HS99007G1 K363299

    Patients

    Seq Age Sex Outcome Treatment
    1