BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT MONITORING SYSTEM

    MDR report key: 5307497 · Received December 17, 2015

    Report

    Report Number
    2027969-2015-01017
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Date of Event
    November 24, 2015
    Report Date
    November 25, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z-0880,0881,0882-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION CANNOT BE PURSUED BECAUSE THERE IS NO LOT NUMBER AND PRODUCT WAS NOT RETURNED. TREND CODE ANALYSIS IS PERFORMED IN THE MONTHLY COMPLAINT REVIEW. THE INRATIO MONITOR IS EXPECTED TO BE RETURNED. INVESTIGATION WILL BE PERFORMED IF/WHEN THE MONITOR IS RETURNED.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: BRAND NAME: REMOVED INRATIO PT/INR TEST STRIPS (AS THE COMPLAINT DEVICE) AND ADDED THE INRATIO PT MONITORING SYSTEM (MONITOR) MODEL #: REMOVED INRATIO PT/INR TEST STRIP AND ADDED THE MONITOR MODEL 100007 INCLUDED SERIAL NUMBER OF THE MONITOR AS ABOVE. CONCOMITANT MEDICAL PRODUCTS: REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS 510K #: REMOVED THE INRATIO PT/INR TEST STRIP 510K # K092987 AND ADDED K072727 TO REFLECT THE INRATIO PT MONITORING SYSTEM. LABELED FOR SINGLE USE? CHANGED FROM "YES" TO "NO" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE USAGE OF DEVICE: CHANGED FROM "UNKNOWN" TO "REUSE" SINCE THE MONITOR IS NOT A SINGLE USE DEVICE. INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. RETAIN STRIP INVESTIGATION WAS NOT PERFORMED ON THE RETURNED MONITOR. THE RECOVERED IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S INRATIO INR RESULT OF 1.3 FROM (B)(6)2015 EXHIBITS CURVE ABNORMALITIES. ABNORMAL CURVES MAY CAUSE THE INRATIO MONITOR SOFTWARE TO GENERATE AN INCORRECT OR DISCREPANT INR RESULT. THIS ISSUE IS RELATED TO THE SOFTWARE ON THE MONITOR AND WAS ADDRESSED IN CAPA-(B)(4). DONOR TESTING OF THE MONITOR WAS NOT NECESSARY DUE TO AN ABNORMAL IMPEDANCE CURVE IDENTIFIED AS THE CAUSE OF CUSTOMER DISCREPANT RESULT. THERMISTOR TESTING WAS PERFORMED ON THE RETURNED MONITOR WITH PASSING RESULTS. IMPROPER TECHNIQUES WERE IDENTIFIED IN THE COMPLAINT. THESE MAY CONTRIBUTE TO UNEXPECTED RESULTS. AS A RESULT OF CAPA-(B)(4), A NEW MONITOR SOFTWARE IS BEING DESIGNED THAT WILL PRODUCE ERROR CODES WHEN ABNORMAL CURVES ARE DETECTED.

    Description of Event or Problem · 1

    THE PATIENT SELF TESTER'S SON PAUL CALLED IN ON HER BEHALF. HE REPORTED A VARIANCE BETWEEN THE INRATIO INR RESULT AND THE POC INR RESULT AND LAB INR RESULT. THE RESULTS WERE AS FOLLOWS: (B)(6): INRATIO=1.3, POC=3.3, (B)(6) : LAB=3.0. THE PATIENT SELF TESTER'S THERAPEUTIC RANGE IS: 2.0-3.0. THE PATIENT SELF TESTER ADDED MULTIPLE DROPS OF BLOOD AND TOUCHED THE SAMPLE WELL WITH HER FINGER WHEN ADDING THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833295 INRATIO PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100007

    Patients

    Seq Age Sex Outcome Treatment
    1