BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5062377 · Received September 8, 2015

    Report

    Report Number
    2027969-2015-00657
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 14, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. FUNCTIONAL AND THERMISTOR TESTING WERE PERFORMED ON THE RETURNED METER WITH PASSING RESULTS. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING. RETAIN STRIPS TESTED ON THE RETURNED METER MET ACCURACY CRITERIA. A REVIEW OF THE ENTIRE IN-HOUSE TESTING FOR LOT 365984A WAS PERFORMED AND FOUND THAT THE LOT MEETS CRITERIA; THE PRODUCT PERFORMED AS EXPECTED. ALTHOUGH RELEVANT NCS WERE NOTED IN THE BATCH RECORD, IT DID NOT AFFECT THE FINAL RELEASE SPECIFICATIONS. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND ADDITIONAL CORRECTIVE ACTIONS WERE NOT REQUIRED. THE IMPEDANCE CURVES ASSOCIATED WITH THE CUSTOMER'S RESULTS WERE DETERMINED TO BE NORMAL IN SHAPE, NOT EXHIBITING WEAK SLOPE OR OTHER ABNORMALITIES. ALTHOUGH AN IMPROPER TECHNIQUE WAS IDENTIFIED IN THE COMPLAINT, A ROOT CAUSE COULD NOT 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. 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 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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION - CORRECTION AND ADDITIONAL INFORMATION: THE CUSTOMER REPORTED TO HAVE OSTEOARTHRITIS WHICH IS A CONDITION WHICH MAY AFFECT THE PERFORMANCE OF THE ASSAY. THE IMPROPER TECHNIQUES IDENTIFIED IN THE COMPLAINT MAY HAVE CONTRIBUTED TO THE OBSERVED PRECISION ISSUE.

    Description of Event or Problem · 1

    PATIENT SELF TESTER CALLED ALLEGING DISCREPANT INRATIO VALUES. PATIENT'S THERAPEUTIC RANGE 2-3. (B)(6) 2015 INRATIO INR = >7.5; REPEAT INRATIO INR = 2.8. TIME BETWEEN TESTS POTENTIALLY GREATER THAN FIVE MINUTES. PATIENT SELF TESTER REPORTED HAD BLED ON THE MONITOR WHEN VIEWING THE INITIAL RESULT ON THE SCREEN. THE MONITOR WAS THEN CLEANED OFF WITH A DAMP CLOTH, DRIED, AND THEN SET FOR A FEW MINUTES TO ALLOW BLOOD INSIDE TO DRY. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593502 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 365984A

    Patients

    Seq Age Sex Outcome Treatment
    1