BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO 2 PT MONITORING SYSTEM

    MDR report key: 4932679 · Received July 22, 2015

    Report

    Report Number
    2027969-2015-00531
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED CONCLUSION: THE METER ASSOCIATED WITH THE CASE WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT OF A DISPLAY ISSUE WAS REPLICATED DURING IN-HOUSE INVESTIGATION. READJUSTING THE DISPLAY RELIEVED ANY EXTRA PRESSURE AND ALLOWED THE LCD SEGMENTS TO DISPLAY PROPERLY. VISUAL INVESTIGATION DID NOT UNCOVER CONTAMINATION ON THE DEVICE. ISSUES OF MISSING SEGMENTS ON INRATIO 2 METER DISPLAY WAS INVESTIGATED AND AS A RESULT, A CORRECTIVE ACTION WAS INITIATED. THIS INSTRUMENT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THE CORRECTIVE ACTIONS THAT WERE IMPLEMENTED. THE LAST SENTENCE ON THE INITIAL MEDWATCH REPORT STATED: 'WHEN THE INVESTIGATION IS FINALIZED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.' THIS SENTENCE SHOULD HAVE READ "HTI INITIATED A SUPPLIER CORRECTIVE ACTION TO ADDRESS THE ISSUE."

    Additional Manufacturer Narrative · 1

    THE METER WAS RETURNED FOR INVESTIGATION. WHEN POWERED UP THE CUSTOMER'S ISSUE WAS OBSERVED. THE LED SCREEN INCORRECTLY DISPLAYED THE PROTHROMBIN TIME (PT). PRODUCT SUPPORT READJUSTED THE DISPLAY RELIEVING ANY EXTRA PRESSURE AND ALLOWED THE LCD SEGMENTS TO FUNCTION AS EXPECTED. FURTHER INSPECTION OF RETURNED METER DID NOT REVEAL ANY MOISTURE NOR SAMPLE CONTAMINATION. THE INRATIO2 MONITOR DISPLAY ISSUE IS BEING THOROUGHLY INVESTIGATED BY THE VENDOR HTI. WHEN THIS INVESTIGATION IS FINALIZED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE LED SCREEN ON THEIR INRATIO MONITOR HAD INCORRECTLY DISPLAYED NUMBERS/LETTERS AS IF SOME LINES WERE NO LONGER FUNCTIONING. THE CENTER LED READOUT WAS NOT WORKING AND DID NOT FORM NUMBERS CORRECTLY. THE CUSTOMER SAID THEY NOTICED THE ISSUE BEFORE CALLING AND WERE UNABLE TO TEST BECAUSE THEY COULD NOT GET PAST THE STRIP CODE VERIFICATION DUE TO THE SCREEN DISPLAY ISSUE. CUSTOMER WAS UNABLE TO TEST OR GET RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477418 INRATIO 2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 55128A

    Patients

    Seq Age Sex Outcome Treatment
    1