BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO PT/INR TEST STRIPS

    MDR report key: 6011985 · Received October 7, 2016

    Report

    Report Number
    2027969-2016-00644
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Report Date
    October 5, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    GJS
    PMA / PMN Number
    K110212
    Removal / Correction Number
    Z-0880, 0881, 0882-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE PRODUCT IS NOT RETURNING FOR EVALUATION. AS THE CUSTOMER WAS UNABLE TO PROVIDE A LOT NUMBER, A MANUFACTURING RECORD REVIEW AND TESTING ON RESERVE SAMPLE FROM THE SAME LOT COULD NOT BE PERFORMED. FURTHER INVESTIGATION IS NOT POSSIBLE AT THIS TIME. HOWEVER, INTERNAL (B)(6) HAD BEEN OPENED TO INVESTIGATE SIGNIFICANTLY LOWER INRATIO INR RESULTS THAN THE REFERENCE RESULT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A (B)(6) 2016 VARIANCE BETWEEN THE INRATIO INR RESULT OF 5.6 AND THE LABORATORY INR RESULT OF 11.3. TIMING BETWEEN TESTS IS UNKNOWN. THERAPEUTIC RANGE: UNKNOWN.

    Description of Event or Problem · 1

    BELOW IS A TIMELINE OF EVENTS AS REPORTED BY CUSTOMER: INITIAL REPORT OF MAY 2016 INRATIO= 5.6 UNCONFIRMED BY HOSPITAL REPORT PROVIDED BY CUSTOMER. THE PATIENT HAD LIGHT ORAL BLEEDING APPROXIMATELY TWO WEEKS PRIOR TO HOSPITALIZATION. THERE IS NO EVIDENCE OR ALLEGATION THAT THE INRATIO INR SYSTEM CAUSED OR CONTRIBUTED TO THE BLEEDING. ON (B)(6) 2016: INRATIO INR RESULT= 6.8. ON (B)(6) 2016: INRATIO INR RESULT= 7.5. THE PATIENT VISITED PHYSICIAN FOR INCREASED ORAL BLEEDING. THE PHYSICIAN ADVISED TO HOLD PHENPROCOUMON AND GO TO HOSPITAL IF CONDITION DID NOT IMPROVE. DOSAGE CHANGE BY PHYSICIAN WAS SUPPORTED BY CLINICAL PRESENTATION. ON (B)(6) 2016: THE PATIENT WAS TAKEN TO THE HOSPITAL VIA AMBULANCE FOR ORAL BLEEDING IN FRONT OF TEETH AND IN LOWER JAW. THE PATIENT ALSO HAD ERYSIPELAS ON LOWER LEFT LEG AFTER INSECT STING. LABORATORY INR RESULT= 11.03 (2:58 PM). THE PATIENT WAS ADMINISTERED VITAMIN K BASED ON THE LABORATORY RESULT AND BLEEDING STOPPED. THE PATIENT WAS ALSO GIVEN AMOCLAV FOR ERYSIPELAS. LABORATORY INR RESULT= 2.29 (8:00 PM). ON (B)(4) 2016: LABATORY INR RESULT= 1.48 (8:00 AM). ON (B)(4) 2016: PATIENT LEFT THE HOSPITAL IN A STABLE GENERAL STATE OF HEALTH. THE PATIENT WAS BORN IN 1945, BUT EXACT DATE OF BIRTH AND AGE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662927 INRATIO PT/INR TEST STRIPS PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO, INC. 99008G1 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 INRATIO PT MONITOR, PN AND SERIAL# UNKNOWN