BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5098890 · Received September 23, 2015

    Report

    Report Number
    2027969-2015-00699
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 STRIP TESTING ON STRIP LOT K363299 MEETS RELEASE SPECIFICATION CRITERIA. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING GOUT TREATMENT. THIS CONDITION MAY IMPACT THE PERFORMANCE OF THE ASSAY. THE 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 AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN (B)(6). THE END USER/PATIENT ALLEGED DISCREPANT HIGH INRATIO INR RESULTS IN COMPARISON TO THE LABORATORY INR RESULTS. RESULTS ARE AS FOLLOWS: (B)(6) 2015: 1ST INRATIO INR=2.7 (LOT# 368059), 2ND INRATIO INR=3.6 (LOT# K363299), 3RD INRATIO INR=3.1 (LOT# 368059), 4TH INRATIO INR=3.7 (LOT# K363299). ALL TESTING PERFORMED WITHIN 40 MINUTES. (B)(6) 2015: LABORATORY INR=2.6 AND 30 MINUTES LATER INRATIO INR=3.7 (LOT# K363299) AND 3.0 (LOT# 368059) 2ND LABORATORY INR=2.4 WHICH WAS PERFORMED 4-5 HOURS LATER. (B)(6) 2015: INRATIO INR=3.9 AND 3.9 (LOT# K363299). THE THERAPEUTIC RANGE WAS 2.5-3.5. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628781 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99007G1 K363299

    Patients

    Seq Age Sex Outcome Treatment
    1