BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIAGE D-DIMER PANEL

    MDR report key: 3522747 · Received November 15, 2013

    Report

    Report Number
    2027969-2013-01036
    Event Type
    Other
    Date Received
    November 15, 2013
    Date of Event
    October 21, 2013
    Report Date
    October 21, 2013
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    GJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE PRODUCT INSERT, EACH LABORATORY SHOULD ESTABLISH A REF RANGE THAT IS REPRESENTATIVE OF THE PATIENT POPULATION TO BE EVALUATED. CUSTOMER WAS PROVIDED TRAINING ON SETTING METER PARAMETERS. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME AS PRODUCT DEFICIENCY WAS NOT ESTABLISHED. PRODUCT IN THIS CASE IS NOT MARKETED/SOLD IN THE U.S. AND THEREFORE DOES NOT HAVE A 510(K) NUMBER.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT D-DIMER RESULTS. PATIENT PRESENTED WITH UNILATERAL SWOLLEN RIGHT CALF. THE LEG WAS NOT RED, HOT OR TENDER BUT WELLS SCORE WAS 2. D-DIMER WAS PERFORMED ON THE METERPRO MACHINE BY THE HEALTHCARE ASSISTANT; RESULT = 4810. THE HEALTHCARE ASSISTANT INTERPRETED THE RESULT AS BEING IN THE NORMAL RANGE. A CO-WORKER THOUGHT THE NORMAL RANGE WAS <400 AND DISCUSSED THE RESULT WITH THE HEALTHCARE ASSISTANT. THE METERPRO MACHINE STATES AND PRINTS THE NORMAL RANGE AS 0-9990, OR ABNORMAL >9990. CUSTOMER WONDERED IF THE MACHINE WAS PROVIDING THE RESULT IN NON-STANDARD UNITS. FURTHER INVESTIGATION REVEALED THAT THE NORMAL RANGE HAD NOT BEEN MANUALLY SET IN THE METER. THE PATIENT WAS ANTICOAGULATED AND AN ULTRASOUND REQUESTED. A DVT WAS CONFIRMED. FOLLOWING THIS EVENT, A SEARCH FOR PATIENTS WITH D-DIMER RESULTS >400 REVEALED FOUR OTHER PATIENTS WHO HAD ELEVATED D-DIMER BUT WERE THOUGHT AT THE TIME TO BE WITHIN THE NORMAL RANGE. ALL THESE PATIENTS HAVE BEEN CALLED IN AND REVIEWED BY A CLINICIAN. FURTHER INVESTIGATION SHOWED THAT TRAINING WAS PERFORMED UPON IMPLEMENTATION OF THE METERPRO. CUSTOMER HAS NO FORMAL RECORD OF TRAINING AS THEY ONLY STARTED TO RECORD TRAINING AS OF APRIL 2013. CUSTOMER FURTHER STATED THAT THERE SHOULD HAVE BEEN SETTING DOCUMENTS ATTACHED TO THE ASSET, BUT WERE NOT THERE. CUSTOMER WAS UNABLE TO DETERMINE IF THE STAFF MEMBER WHO INSTALLED THE INSTRUMENT DISCUSSED THESE SETTINGS AT THE TIME OF IMPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594861 TRIAGE D-DIMER PANEL CARDIAC MARKER PANEL GJS ALERE SAN DIEGO INC 98100EU WE1684RB

    Patients

    Seq Age Sex Outcome Treatment
    1