BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 4972897 · Received August 3, 2015

    Report

    Report Number
    3004193489-2015-00113
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 25, 2015
    Report Date
    July 25, 2015
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL. TEST STRIP LOT # 1020209103 EXPIRATION DATE: 04/2011 CONTROL SOLUTION LOT NONE. PER LABEL COPY/ PACKAGE INSERT. UNEXPECTED RESULTS. HIGH OR LOW BLOOD GLUCOSE RESULTS CAN INDICATE POTENTIALLY SERIOUS MEDICAL CONDITIONS. IN CASE OF AN UNEXPECTED RESULT, YOU SHOULD REPEAT THE TEST USING A NEW TEST STRIP. IF THE RESULT IS STILL UNEXPECTED, OR THE READING IS NOT CONSISTENT WITH HOW YOU FEEL, CONTACT YOUR HCP AND TREAT AS PRESCRIBED. NOVA MAX TEST STRIP INSERT- QUALITY CONTROL CHECKING THE SYSTEM CONTROL SOLUTION TEST: THE NOVA MAX CONTROL SOLUTION IS USED AS A QUALITY CONTROL CHECK TO MAKE SURE THAT YOUR BLOOD GLUCOSE MONITOR AND THE NOVA MAX GLUCOSE TEST STRIPS ARE WORKING CORRECTLY. DO A CONTROL SOLUTION TEST: EACH TIME YOU OPEN A NEW VIAL OF TEST STRIPS. NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE CONSUMER'S COMPLAINT COULD NOT BE CONFIRMED. ANALYSIS OF THE RETURNED NOVA MAX LINK BLOOD GLUCOSE MONITOR REVEALED THE DEVICE PERFORMS AS INTENDED. THE MONITOR WAS FOUND TO MEET ALL TEST SPECIFICATIONS. THE RETURNED BLOOD GLUCOSE TEST STRIPS COULD NOT BE EVALUATED. THE STRIPS EXPIRED APRIL 2011. ROOT CAUSE ATTRIBUTED TO USER ERROR DUE TO USE OF EXPIRED BLOOD GLUCOSE TEST STRIPS.

    Description of Event or Problem · 1

    CONSUMER CALLED INTO CUSTOMER CARE REPORTING AN INCIDENT THIS MORNING WHEN THE EMTS WERE CALLED TO HIS HOUSE DUE TO SYMPTOMS OF LOW BG. CONSUMER AWOKE AROUND 3:30 AM AND WAS VERY DISORIENTED. HIS WIFE WOKE UP AND CALLED THE EMT'S AROUND 3:40 AM. ACCORDING TO THE CONSUMER HE PERFORMED A BLOOD GLUCOSE TEST AT 3:43AM GETTING A RESULT OF 97 MG/DL. WHEN THE EMTS PERFORMED A BLOOD GLUCOSE TEST USING THEIR UNK BRAND METER GETTING A RESULT OF 39 MG/DL. THE CONSUMER WAS TREATED WITH EMERGENT FOOD INTERVENTION TO HELP RAISE HIS BLOOD GLUCOSE LEVEL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT PERFORM A CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. WHILE ON THE PHONE, A CONTROL SOLUTION COULD NOT BE PERFORMED BECAUSE THE CONSUMER DID NOT HAVE ANY CONTROL SOLUTION. IT WAS ALSO REVEALED THAT THE CONSUMER WAS USING EXPIRED TEST STRIP, WHICH MAY CONTRIBUTE TO THE LOSS OF INTEGRITY OF THE TEST STRIPS. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505677 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020209103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other