BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT MONITORING SYSTEM

    MDR report key: 5567318 · Received April 11, 2016

    Report

    Report Number
    2027969-2016-00220
    Event Type
    Injury
    Date Received
    April 11, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 16, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 1

    PLEASE MAKE THE FOLLOWING CORRECTIONS: CORRECT BRAND NAME TO READ: INRATIO2 PT MONITORING SYSTEM. CORRECT MODEL AND LOT # TO READ: MODEL #200432. CHANGE CONCOMITANT MEDICAL PRODUCTS FROM "INRATIO MONITOR SN (B)(4)" TO "INRATIO PT/INR TEST STRIPS, MODEL #100071". CORRECT PMA# TO READ: K072727. CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S RESULT OF 1.1 FOUND THAT THE CURVE EXHIBITED AN ABNORMAL SHAPE. CAPA INVESTIGATION (CAPA (B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE AND AN ABNORMAL SHAPE CAN CAUSE DISCREPANT RESULTS. THE INRATIO MONITOR SOFTWARE MAY GENERATE AN INCORRECT OR DISCREPANT INR RESULT WHEN THE PATIENT SAMPLE EXHIBITS A WEAK-SLOPE CHANGE IMPEDANCE CURVE. THE CAPA INVESTIGATION HAS ALSO DETERMINED THAT CERTAIN PATIENT CONDITIONS CAN CONTRIBUTE TO WEAK SLOPE CHANGE IMPEDANCE CURVES. THERE ARE NO KNOWN PATIENT CONDITIONS PROVIDED BY THE CUSTOMER THAT WOULD LEAD TO THE OBSERVED WEAK SLOPE CHANGE. DONOR TESTING WAS NOT PURSUED DUE TO THE SOFTWARE ISSUE BEING IDENTIFIED AS THE ROOT CAUSE OF THE CUSTOMER'S DISCREPANT RESULTS. THE RETURNED MONITOR MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS. A REVIEW OF THE ENTIRE TESTING HISTORY FOR LOT 378770A WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT 378770A MEETS RELEASE CRITERIA. THE MANUFACTURING RECORDS FOR THE LOT 378770A WERE REVIEWED AND DID NOT UNCOVER ANY NON-CONFORMANCES. LOT MET RELEASE SPECIFICATIONS. CAPA (B)(4) IDENTIFIED IMPEDANCE CURVES WITH WEAK SLOPES AND ABNORMAL SHAPES AS POTENTIALLY LEADING TO DISCREPANT INR VALUES. FURTHER INVESTIGATION IS BEING PERFORMED UNDER CAPA (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TELEPHONE CALL THAT ON (B)(6) 2016, THE PATIENT'S INRATIO INR WAS 1.1. THE PATIENT'S THERAPEUTIC RANGE WAS 2.0 - 3.0. AFTER THE INRATIO INR RESULT WAS REPORTED TO THE PHYSICIAN, THE PHYSICIAN REQUESTED THAT THE PATIENT HAVE A LABORATORY INR DRAWN FOR COMPARISON. THE LABORATORY INR WAS 5.1. THE TIME BETWEEN TESTING WAS SIX (6) HOURS. THE PATIENT WAS HOSPITALIZED FOR ELEVATED INR. AT THIS TIME, NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224452 INRATIO2 PT MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432 378770A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization