BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT/INR TEST STRIP

    MDR report key: 5481600 · Received March 4, 2016

    Report

    Report Number
    2027969-2016-00137
    Event Type
    Injury
    Date Received
    March 4, 2016
    Date of Event
    January 16, 2016
    Report Date
    February 8, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INCLUDED AN INCORRECT DATE OF (B)(6) 2015. THE DATE SHOULD BE (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE METER AND STRIPS ASSOCIATED WITH THE COMPLAINT WERE RETURNED FOR INVESTIGATION. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVES ASSOCIATED WITH THE CUSTOMER'S RESULT OF 3.1 FOUND THAT THE CURVES EXHIBITED A WEAK-SLOPE CHANGE. A STATISTICAL ANALYSIS OF THE IMPEDANCE CURVE ASSOCIATED WITH THE CUSTOMER'S RESULT OF 2.8 FOUND THAT THE CURVE EXHIBITED A WEAK-SLOPE CHANGE AND AN ABNORMAL SHAPE. CAPA INVESTIGATION (B)(4) HAS DETERMINED THAT IMPEDANCE CURVES WITH WEAK SLOPE CHANGE AND AN ABNORMAL SHAPE CAN CAUSE DISCREPANT RESULTS. THE INRATIO METER 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 METER MET FUNCTIONAL AND THERMISTOR TESTING REQUIREMENTS. A REVIEW OF THE ENTIRE TESTING HISTORY FOR LOT K370019 WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K370019 MEETS RELEASE CRITERIA. THE MANUFACTURING RECORDS FOR THE LOT K370019 WERE REVIEWED AND DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. LOT MEETS RELEASE SPECIFICATIONS. IMPEDANCE CURVES WITH WEAK-SLOPE CHANGE AND AN ABNORMAL SHAPE HAVE BEEN IDENTIFIED IN (B)(4) TO CONTRIBUTE TO A POTENTIAL DISCREPANT RESULT. FURTHER INVESTIGATION IS BEING PERFORMED UNDER (B)(4) FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. THEREFORE, A REVIEW OF IN-HOUSE TESTING WAS PERFORMED. IN-HOUSE TESTING ON STRIP LOT K370019 MET RELEASE CRITERIA AND THE PRODUCT PERFORMED AS EXPECTED. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. SINCE THE MONITOR WAS NOT RETURNED, THE IMPEDANCE CURVE ASSOCIATED WITH THE REPORTED RESULT COULD NOT BE ANALYZED FOR CHARACTERISTICS OF A WEAK-SLOPE CHANGE. INTERNAL INVESTIGATION (CAPA (B)(4)) HAS DETERMINED THAT IMPEDANCE CURVES WITH ABNORMAL SLOPE CHANGE CAN CAUSE DISCREPANT RESULTS. A ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME WITHOUT PRODUCT RETURN.

    Description of Event or Problem · 1

    THE INITIAL MEDWATCH REPORT INCLUDED AN INCORRECT DATE OF (B)(6) 2015. THE DATE SHOULD BE (B)(6) 2015 (THE INRATIO INR RESULT OF 6.7 ON THIS DATE IS CORRECT).

    Description of Event or Problem · 1

    THE EVENT OCCURRED IN THE (B)(6) ON A PATIENT WHO WAS UNDERGOING THROMBOSIS TREATMENT WITH ACENOCOUMAROL. THE FOLLOWING INFORMATION WAS REPORTED BY THE PATIENT'S SPOUSE. HISTORICAL INRATIO INR RESULTS: (B)(6) 2015: 3.1, (B)(6) 2015: 2.7, (B)(6) 2015: 2.5, (B)(6) 2015: 2.5, (B)(6) 2015: 3.3, (B)(6) 2015: 6.7, (B)(6) 2016: 2.3, (B)(6) 2016: 2.3, (B)(6) 2016: 2.8. PRIOR TO THE EVENT ON (B)(6) 2016, THE LAST INRATIO INR RESULT WAS 2.8 ((B)(6) 2016). ON (B)(6) 2016, AN (B)(6) FEMALE PATIENT WAS NOT FEELING WELL. IT IS UNKNOWN IF THE PATIENT LOST CONSCIOUSNESS AND FELL TO THE FLOOR OR IF THE PATIENT FELL AND THEN LOST CONSCIOUSNESS. THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE HOSPITAL WHERE SHE WAS ADMITTED. THE INRATIO INR RESULT WAS 3.1 AND THE LABORATORY INR RESULT WAS 12. IT IS UNKNOWN WHAT TREATMENTS WERE PROVIDED DURING THE HOSPITALIZATION. IT WAS REPORTED, BY THE SPOUSE, THAT THE PATIENT WAS VERY CRITICAL BUT SURVIVED AND THE FINAL DIAGNOSIS OF THE PATIENT WAS CARDIAC ARRHYTHMIA. ADDITIONALLY, THE CARDIOLOGIST PRESCRIBED UNKNOWN MEDICATION WHERE "PUNCTURE" WAS NOT NECESSARY. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137523 INRATIO2 PT/INR TEST STRIP INRATIO2 PT/INR MONITORING SYSTEM GJS ALERE SAN DIEGO, INC. 200433 K370019

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R