BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLEARVIEW SIMPLIFY D-DIMER

    MDR report key: 842263 · Received April 24, 2007

    Report

    Report Number
    8020026-2007-00002
    Event Type
    Death
    Date Received
    April 24, 2007
    Date of Event
    February 14, 2007
    Report Date
    April 23, 2007
    Manufacturer
    AGEN BIOMEDICAL LTD.
    Product Code
    GHH
    PMA / PMN Number
    k993276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT POSSIBLE TO DETERMINE WHETHER THE CLEARVIEW SIMPLIFY D-DIMER DEVICE USED TO TEST THE PATIENT IN QUESTION PRODUCED AN ACCURATE TEST RESULT OR NOT. IN ACCORDANCE WITH HOSPITAL PROCEDURE, THE PATIENT WAS SENT HOME AND THEREFORE, NO SCAN WAS PERFORMED WHICH WOULD HAVE CONFIRMED THE PRESENCE OF ANY CLOT AT THAT POINT IN TIME. NO BLOOD SAMPLE WAS AVAILABLE FOR TESTING BY ANOTHER METHOD. HOWEVER, THE WELLS SCORE WAS LOW WHICH INDICATES LOW PROBABILITY AND SUPPORTS THE RESULT OBTAINED WITH THE CLEARVIEW SIMPLIFY D-DIMER SUPPORT. IN ADDITION, THE OBSERVATION MADE BY THE PATIENT'S GP WAS THAT HE "APPEARED IN FINE HEALTH WITH NO SHORTNESS OF BREATH BUT HAD A COUGH." THIS INDICATES THE PATIENT WAS NOT SHOWING SIGNS AND SYMPTOMS OF DVT AT THE TIME OF PRESENTATION TO THE DOCTOR. A REVIEW OF OUR PRODUCT LABELING IS TO BE CARRIED OUT AND CHANGES WILL BE MADE IF DEEMED APPROPRIATE.

    Description of Event or Problem · 1

    A MALE PATIENT WAS SEEN AT THE HOSPITAL AND ASSESSED FOR SUSPECTED DVT. THE WELLS PRE-TEST PROBABILITY SCORE WAS DESCRIBED BY THE HOSPITAL AS LOW (=1) INDICATING A LOW PROBABILITY OF DVT AND THE RESULT OBTAINED WITH THE CLEARVIEW SIMPLIFY D-DIMER TEST WAS NEGATIVE. THE SAMPLE USED IN THE CLEARVIEW SIMPLIFY D-DIMER TEST WAS VENOUS WHOLE BLOOD AND THE NURSE READ THE TEST AT THE INSTRUCTED READ TIME OF 10 MINUTES. UPON EXAMINATION, THE PATIENT'S LEG WAS NOT SWOLLEN. DVT WAS RULED OUT ON THE BASIS OF THE WELLS PRE-TEST PROBABILITY SCORE, CLEARVIEW SIMPLIFY D-DIMER RESULT AND EXAMINATION AS A RESULT, THE PATIENT WAS SENT HOME. THIS WAS IN ACCORDANCE WITH THE HOSPITAL'S PROTOCOL, THAT IS, A PATIENT PRESENTING AT THE HOSPITAL WITH A SUSPECTED DVT WOULD HAVE A WELLS PRE-TEST PROBABILITY SCORE. IF THIS IS LOW, THEN THE PATIENT IS TESTED WITH THE CLEARVIEW SIMPLIFY D-DIMER TEST AND IF THE RESULT IS NEGATIVE, THE PATIENT IS SENT HOME. IF THE CLEARVIEW SIMPLIFY D-DIMER TEST IS POSITIVE, THEN THE PATIENT IS SENT FOR A SCAN. THE PATIENT VISITED HIS GP AND HIS CONDITION WAS DESCRIBED BY HIS GP AS "APPEARED IN FINE HEALTH, NO SHORTNESS OF BREATH BUT HAD A COUGH." THE GP PRESCRIBED ANTIBIOTICS TO TREAT THE SUSPECTED UPPER RESPIRATORY TRACT INFECTION. THE PATIENT DIED THREE DAYS LATER. THE PATIENT WAS SAID (BY THE CORONER) TO HAVE HAD A MASSIVE EMBOLI IN BOTH MAIN PULMONARY ARTERIES ORIGINATING FROM A DVT. THE PATIENT DIED 8 DAYS AFTER TESTING WITH CLEARVIEW SIMPLIFY D-DIMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARVIEW SIMPLIFY D-DIMER GHH GHH AGEN BIOMEDICAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death