BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO2

    MDR report key: 2287938 · Received October 7, 2011

    Report

    Report Number
    2027969-2011-02093
    Event Type
    Death
    Date Received
    October 7, 2011
    Date of Event
    September 10, 2011
    Report Date
    October 7, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K072727
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ALERE TECHNICAL SERVICES CONTACTED THE CUSTOMER ON (B)(6) 2011 AND ATTEMPTED TO CONTACT THE CUSTOMER AGAIN ON (B)(6) 2011. HOWEVER, THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER INFO REGARDING THE HOSPICE PT'S DIAGNOSIS OR CAUSE OF DEATH. CUSTOMER WAS ALSO UNABLE TO PROVIDE FURTHER INFO AS TO WHICH METER OR STRIP LOT MAY HAVE BEEN USED TO TEST THE PT. CUSTOMER (B)(6) CALLED BACK ON (B)(6) 2011 AND STATED THAT HOSPICE PT HAD TERMINAL LUNG CANCER AND THAT A LIVER MASS WAS SUSPECTED AS WELL. THE CUSTOMER REPORTS THAT IN THE PAST, THEY HAVE OBTAINED VALID HIGH INR VALUES FOR THE HOSPICE PT AND HELD HER COUMADIN ACCORDINGLY. HOWEVER, IN THE PAST, EVEN WHEN THE PT STOPPED TAKING COUMADIN, IT TOOK A VERY LONG TIME FOR HER INR TO BEGIN DECREASING. THE CUSTOMER DOES NOT BELIEVE THAT THE HIGH INR AND/OR BLEEDING ARE THE REASON FOR THE PT'S DEATH, ALTHOUGH SHE COULD NOT DETERMINE DEFINITIVELY. CUSTOMER REPORTS THAT THE NEW STRIPS THEY WERE SENT SEEM TO BE WORKING WELL AND THAT THEY HAVE HAD NO FURTHER ISSUES WITH THE NEW STRIPS. CUSTOMER INFORMED ALL NURSES THAT IF ANY UNEXPECTED RESULTS ARE OBTAINED, THEY SHOULD AUTOMATICALLY DO A VENIPUNCTURE FOR COMPARISON. TECHNICAL SERVICES WAS ABLE TO GET THE TWO ADD'L METER SERIAL NUMBERS BY FOLLOWING UP WITH CUSTOMER AN ADD'L FOUR TIMES ON (B)(6) 2011. BECAUSE THE CUSTOMER IS UNABLE TO DETERMINE WHICH METER WAS USED, THE FOLLOWING FIVE MEDWATCH REPORTS HAVE BEEN FILED FOR THE SAME DEATH/INCIDENT WITH EACH OF THE DIFFERENT KNOWN METER SERIAL NUMBERS: 2027969-2011-02091, 02092, 02094, 02095, 02096. THESE ADD'L MEDWATCH REPORTS ARE FOR THE SAME SINGLE DEATH AND DO NOT REFLECT SEPARATE INCIDENTS. METER IS EXPECTED TO BE RETURNED FOR INVESTIGATION BY 10/21/2011.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES DISCREPANT RESULTS WITH METER COMPARED TO LAB. CUSTOMER BELIEVES THE ALLEGED DISCREPANCY OCCURRED ON (B)(6) 2011 WHEN THE INRATIO METER GAVE A RESULT OF INR=3.7 FROM A HOSPICE PT'S RIGHT HAND, AND INR=7.4 FROM THE LEFT HAND. CUSTOMER IS UNCERTAIN WHEN THE LAB COMPARISON WAS DONE, BUT STATED THAT IT IS THEIR POLICY TO OBTAIN A LAB DRAW WITHIN 1 HR OF ANY QUESTIONABLE RESULT. THE LAB COULD NOT CALCULATE AN INR BECAUSE THE RESULT WAS OUTSIDE THE MEASURABLE RANGE. THE LAB RESULTED A PT= >100. THE HOSPICE PT IS REPORTED TO HAVE PASSED AWAY SUNDAY (B)(6) 2011. CUSTOMER ALLEGES THAT NURSES HAVE REPORTED INACCURACIES WITH AT LEAST SIX METERS, BUT ONLY FOUR SERIAL NUMBERS WERE INITIALLY KNOWN. CUSTOMER DID NOT KNOW WHICH METER WAS USED FOR HOSPICE PT'S TESTING. CUSTOMER CANNOT DETERMINE WHICH LOT WAS USED BECAUSE THEY DO NOT DOCUMENT THE STRIP LOT NUMBER WHEN TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INRATIO2 PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 100139 NG

    Patients

    Seq Age Sex Outcome Treatment
    1 Death