BEUDAMED
    FDA Adverse Event Death Summary report: N

    INRATIO2 PT/INR MONITORING SYSTEM

    MDR report key: 4888665 · Received July 2, 2015

    Report

    Report Number
    2027969-2015-00440
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    April 11, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION, EVALUATED AND MET SPECIFICATIONS. THE MONITOR MEMORY WAS REVIEWED. THE INRATIO INR RESULT OF 1.8 ON (B)(6) 2014, WHICH WAS REPORTED BY THE CUSTOMER, IS NOT PRESENT. SINCE THE RESULT WAS NOT PRESENT IN THE MONITOR MEMORY, THE IMPEDANCE CURVE ASSOCIATED WITH THE DISCREPANT RESULT COULD NOT BE ANALYZED. THE RETAIN STRIP TESTING ON THE RETURNED MONITOR MET BOTH ACCURACY AND STRIP REPEATABILITY CRITERIA. A REVIEW OF THE BATCH RECORD FOR THE LOT DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES AND THE LOT MET RELEASE SPECIFICATION. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER. THE COMPLAINT WAS NOT CONFIRMED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY IN THIS CASE WITH THE INRATIO TEST STRIPS. FURTHER INVESTIGATION OF DISCREPANT LOW INRATIO RESULTS IS DOCUMENTED IN (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014 A NURSE FROM A MEDICAL FACILITY NOTIFIED ALERE (B)(4) THAT A PATIENT SELF-TESTER WHO HAD DISCREPANT INR RESULTS HAD PASSED AWAY. THE FOLLOWING SEQUENCE OF INR VALUES WERE REPORTED BY THE NURSE: (B)(6) 2014: INRATIO=1.9. (B)(6) 2014: INRATIO=4.0 (COUMADIN DOSE DECREASED ON THIS DATE). (B)(6) 2014: INRATIO=1.8 (COUMADIN DOSE INCREASED ON THIS DATE). ON (B)(6) 2014, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH SYMPTOMS OF HEADACHE, DISORIENTATION AND CONFUSION. THE PATIENT HAD MULTIPLE CO-MORBIDITIES INCLUDING MALIGNANT HYPERTENSION, KIDNEY FAILURE, AND OTHER UNSPECIFIED ISSUES. THE PATIENT WAS DIAGNOSED WITH A RIGHT PARIETAL HEMORRHAGE. ON (B)(6) 2014, A LABORATORY INR VALUE OF 4.9 WAS REPORTED. THE PATIENT WAS GIVEN VITAMIN K AND TWO UNITS OF FRESH, FROZEN PLASMA TO ADDRESS THE HIGH INR VALUE. THE PATIENT'S INR THEN DROPPED TO BELOW 3.0. THE NURSE REPORTED THE PATIENT HAD NO NEUROLOGICAL DAMAGE FROM THE BLEED (RIGHT PARIETAL HEMORRHAGE). ON (B)(6) 2014, THE PATIENT WAS DISCHARGED AND WENT TO A HOSPICE ON (B)(6) 2014. DIALYSIS WAS DISCONTINUED AND THE PATIENT DIED ON (B)(6) 2014. BETWEEN (B)(6) 2014, ASD HAD SEVERAL WRITTEN AND ORAL COMMUNICATIONS WITH THE REPORTING NURSE TO OBTAIN ADDITIONAL INFORMATION. ON (B)(6) 2014, THE NURSE STATED THAT THE PATIENT DIED OF KIDNEY FAILURE AND THAT THE PATIENT'S DEATH WAS NOT DUE TO AN INRATIO RESULT OR INR. ON (B)(6) 2014, THE NURSE INFORMED ASD THAT SHE COULD NOT VERIFY THE CAUSE OF DEATH AND THAT NO AUTOPSY WAS PERFORMED. ON (B)(6) 2014, THE NURSE CONTACTED ASD AND SAID THE FORM FILLED OUT TO REPORT A DEATH AT THE FACILITY LISTED BRAIN HEMORRHAGE AS THE CAUSE OF DEATH. SHE ALSO CLARIFIED THAT THE PATIENT WAS INITIALLY ADMITTED FOR "NON-TRAUMATIC BRAIN HEMORRHAGE". ASD IS CONSERVATIVELY FILING THIS EVENT AS AN MDR WITH "DEATH" AS THE TYPE OF REPORTABLE EVENT BECAUSE THE ALLEGED INRATIO DISCREPANT RESULT CANNOT BE RULED OUT IN THESE CIRCUMSTANCES AND, ALTHOUGH THE PATIENT HAD KIDNEY FAILURE AND CHOSE TO GO ON HOSPICE RATHER THAN UNDERGO DIALYSIS, THE HOSPITAL FORM REPORTEDLY LISTED BRAIN HEMORRHAGE AS THE CAUSE OF DEATH AND IT CANNOT BE RULED OUT THAT THE BRAIN BLEED CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432354 INRATIO2 PT/INR MONITORING SYSTEM PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 200432

    Patients

    Seq Age Sex Outcome Treatment
    1 Death WARFARIN/COUMADIN 50MG WEEKLY| ALBUTEROL INHALER| INRATIO PT/INR TEST STRIPS 100071, LOT# 332831| OTHER UNSPECIFIED MEDICATIONS