BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5135856 · Received October 8, 2015

    Report

    Report Number
    2027969-2015-00831
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 6, 2015
    Report Date
    September 10, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING. RETAIN STRIPS TESTED ON THE RETURNED METER MET ACCURACY CRITERIA. WHEN REVIEWING THE ENTIRE IN-HOUSE TESTING HISTORY FOR LOT 372984A, IT WAS FOUND THAT THE LOT MEETS RELEASE CRITERIA. THE PRODUCT PERFORMED AS EXPECTED. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT 372984A DID NOT UNCOVER ANY NON-CONFORMANCES. THE LOT MEETS RELEASE SPECIFICATION. THE RETURNED METER PASSED FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS DURING IN-HOUSE INVESTIGATION. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CORRECTIONS: BRAND NAME: REMOVED INRATIO PT/INR TEST STRIPS (AS THE COMPLAINT DEVICE) AND ADDED THE INRATIO2 PT MONITORING SYSTEM (MONITOR). MODEL #: REMOVED INRATIO PT/INR TEST STRIP AND ADDED THE MONITOR MODEL 200432. LOT#: REMOVED INRATIO PT/INR TEST STRIP LOT NUMBER AND INCLUDED SERIAL NUMBER OF MONITOR AS ABOVE. CONCOMITANT PRODUCT(S): REMOVED THE MONITOR AS A CONCOMITANT MEDICAL PRODUCT AND ADDED THE INRATIO PT/INR TEST STRIPS. PMA 510K#: REMOVED THE INRATIO PT/INR TEST STRIP 510K# K092987 AND ADDED K072727 TO REFLECT THE INRATIO2 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Description of Event or Problem · 1

    PATIENT SELF TESTER'S SON-IN-LAW CALLED ALLEGING PATIENT HAD RECEIVED DISCREPANT HIGH INRATIO VALUES. (B)(6) 2015 INRATIO REPORTED TO BE IN THE HIGH 4S OR LOW 5S. (B)(6) 2015 LAB = 2.4. PATIENT'S THERAPEUTIC RANGE 2 - 3. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668856 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 372984A

    Patients

    Seq Age Sex Outcome Treatment
    1