BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5297905 · Received December 15, 2015

    Report

    Report Number
    2027969-2015-01011
    Event Type
    Malfunction
    Date Received
    December 15, 2015
    Report Date
    December 4, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 K370019 WAS PERFORMED AND FOUND TO BE PERFORMING WITHIN EXPECTATIONS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. IT WAS REPORTED THAT THE PATIENT HAD APS. THIS CONDITION CAN IMPACT THE PERFORMANCE OF THE ASSAY. TESTING WITH AN APS-INSENSITIVE LABORATORY METHOD IS RECOMMENDED FOR THESE PATIENTS. THE PATIENT'S SAMPLE MAY HAVE INTERFERED WITH THE TEST AND CANNOT BE RULED OUT AS A POSSIBLE ROOT CAUSE FOR THE DISCREPANCY OBSERVED BY THE CUSTOMER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    A PHYSICIAN'S OFFICE IN (B)(6) REPORTED A VARIANCE BETWEEN INRATIO2 INR RESULTS. RESULTS ARE AS FOLLOWS: DATE: NOT PROVIDED, INRATIO2 INR: 1.0 AND 2.1. THE PHYSICIAN FELT THAT THE 1.0 WAS IMPROBABLE AS THE PATIENT WAS ON PHENPROCOUMON. THERAPEUTIC RANGE: NOT PROVIDED. TESTING WAS PERFORMED ONE AFTER THE OTHER. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT HAS ANTIPHOSPHOLIPID SYNDROME (APS). (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826132 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K370019

    Patients

    Seq Age Sex Outcome Treatment
    1