BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INRATIO2 PT/INR PROFESSIONAL TEST STRIPS

    MDR report key: 5231055 · Received November 17, 2015

    Report

    Report Number
    2027969-2015-00933
    Event Type
    Injury
    Date Received
    November 17, 2015
    Date of Event
    September 12, 2015
    Report Date
    October 19, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITOR ASSOCIATED WITH THE COMPLAINT WAS NOT RETURNED FOR INVESTIGATION. AS A RESULT, RETAINED STRIPS FROM LOT K372403 WERE TESTED WITH IN-HOUSE MONITORS. THE CUSTOMER'S COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE INVESTIGATION. A REVIEW OF THE ENTIRE LOT TESTING HISTORY WAS PERFORMED AND THE LOT MET EXPECTATIONS. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT K372403 DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCES. LOT MEETS RELEASE SPECIFICATIONS. THE IMPEDANCE CURVES FOR THE REPORTED INRATIO INR RESULTS COULD NOT BE ANALYZED BECAUSE THE MONITOR WAS NOT RETURNED FOR INVESTIGATION. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DEVICE IS NOT AVAILABLE FOR EVALUATION, INVESTIGATION TO DETERMINE A POTENTIAL MALFUNCTION IS PENDING. A REVIEW WAS PERFORMED BY ALERE'S MEDICAL ADVISOR TO DETERMINE IF THERE IS ANY ASSOCIATION BETWEEN THE INRATIO DEVICE AND THE EVENT. BASED ON THE INFORMATION PROVIDED, INCLUDING THE PHYSICIAN'S STATEMENT THAT INDICATED BLEEDING DID NOT CONTRIBUTE TO THE PATIENT'S DEATH BUT THAT THE CAUSE OF DEATH WAS HEART FAILURE, THERE IS NO REASONABLE SUSPICION THAT THE INRATIO DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    A PHYSICIAN CUSTOMER REPORTED TWO VARIANCES BETWEEN A PATIENT'S INRATIO INR RESULTS FROM POC TESTING AND LABORATORY INR RESULTS. BOTH REPORTED DISCREPANT RESULTS WERE OBTAINED DURING THE SAME WEEK (EXACT DATES UNKNOWN). THE RESULTS ARE AS FOLLOWS: EVENT 1: INRATIO 1.9, LAB >5.8, EVENT 2: INRATIO 2.1, LAB >8. PATIENT'S THERAPEUTIC RANGE WAS: 2-3. PATIENT WAS HOSPITALIZED ON (B)(6) 2015 AND GIVEN VITAMIN K. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS MULTIMORBID, SUFFERING FROM MANY DIFFERENT DISEASES INCLUDING RENAL INSUFFICIENCY AND WATER IN THE LUNG. THE PHYSICIAN REPORTED THAT THE PATIENT DIED FROM HEART FAILURE AND THAT THE DEATH WAS NOT DUE TO A BLEED. THE PHYSICIAN ALSO REPORTED THAT THE PATIENT'S HEMATOCRIT WAS 38% PRIOR TO HOSPITALIZATION AND 39% IN THE HOSPITAL (RANGE PER PACKAGE INSERT IS 25-53%). ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION ABOUT THE HOSPITAL, HOSPITALIZATION DATES, OR DATE OF DEATH COULD BE OBTAINED, NOR COULD A COPY OF THE PATIENT'S DEATH CERTIFICATE BE OBTAINED. NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR TO A DEVICE AVAILABLE IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759643 INRATIO2 PT/INR PROFESSIONAL TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 K372403

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R