BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT/INR TEST STRIPS

    MDR report key: 5218021 · Received November 11, 2015

    Report

    Report Number
    2027969-2015-00922
    Event Type
    Malfunction
    Date Received
    November 11, 2015
    Date of Event
    October 10, 2015
    Report Date
    October 16, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    STRIP LOT K333796 EXPIRED IN OCTOBER 2014. NO OTHER COMPLAINTS WERE REPORTED FOR THIS STRIP LOT WHILE IT WAS WITHIN EXPIRATION. THEREFORE, NO INVESTIGATION WAS PERFORMED ON THIS LOT PRIOR TO ITS EXPIRATION. A REVIEW OF THE MANUFACTURING RECORDS FOR STRIP LOT K333796 DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. THE CUSTOMER WAS USING A PRODUCT WHICH HAD ALREADY BEEN EXPIRED FOR APPROXIMATELY A YEAR WHEN THEIR INRATIO TEST WAS PERFORMED. THIS CANNOT BE RULED OUT AS A CAUSE FOR THE UNEXPECTED RESULT. 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

    THIS INCIDENT OCCURRED IN (B)(6). THE CALLER ALLEGED A VARIANCE BETWEEN INRATIO INR RESULTS AND THE LAB INR RESULTS. ON (B)(6) 2015, A PATIENT BROUGHT HIS INSTRUMENT BACK TO THE PHARMACY AND REQUESTED THAT THE VALUE RANGES BE CHECKED TO COMPARE WITH THE RESULTS OBSERVED WHEN HE TESTED HIMSELF ON (B)(6) 2015. THE RESULTS ON THAT DATE WERE AS FOLLOWS: INR RESULTS = 1.2 WHILE THE LAB INR = 2.4. THERAPEUTIC RANGE: NOT AVAILABLE. ALTHOUGH REQUESTED, NO FURTHER INFORMATION IS AVAILABLE. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE US).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748820 INRATIO2 PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99007EU K333796

    Patients

    Seq Age Sex Outcome Treatment
    1