BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2

    MDR report key: 3770348 · Received March 7, 2014

    Report

    Report Number
    2027969-2014-00198
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 18, 2014
    Manufacturer
    ALERE SAN DIEGO
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED DISCREPANT HIGH INRATIO INR RESULTS DURING TESTING. THE CUSTOMER DID NOT PROVIDE REFERENCE VALUES FOR COMPARISON TESTING. THE ACCURACY OF THE INRATIO INR RESULTS COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVAL. THEREFORE, INVESTIGATION OF THE COMPLAINT TO DETERMINE ROOT CAUSE CANNOT BE COMPLETED. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFO PROVIDED BY THE CUSTOMER. SINCE THE PRODUCT ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED, RETAIN TESTING WAS PERFORMED DURING AN IN-HOUSE INVESTIGATION. RETAIN STRIP TESTING RESULTS MET BOTH ACCURACY AND REPEATABILITY CRITERIA. THE PRODUCT PERFORMED AS EXPECTED AND NO PRODUCT DEFICIENCIES WERE OBSERVED. THE MFG RECORDS FOR THE LOT WERE REVIEWED. THE NON-CONFORMANCES ASSOCIATED WITH THIS LOT WERE REVIEWED. THE NON-CONFORMANCES ASSOCIATED WITH THIS LOT WERE NOT RELEVANT TO THE INITIAL COMPLAINT AND DOES NOT AFFECT PRODUCT PERFORMANCE. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME. BASED ON THE INFO AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED LOW RESULTS. TESTS PERFORMED ON THE SAME DAY ARE WITHIN 5 MINUTES OF EACH OTHER. THERAPEUTIC RANGE: 2-3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140168 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO 100139 312583

    Patients

    Seq Age Sex Outcome Treatment
    1 METOPROLOL 7.5 MG| WARFARIN 5 MG 3/WEEK 2.5 MG 4/WEEK| AMIODARONE 200 MG| TYLENOL AS NEEDED FOR PAIN| PLAVIX| LIPITOR 80MG| FUROSEMIDE 10MG/DAY