BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 4972925 · Received August 3, 2015

    Report

    Report Number
    3004193489-2015-00111
    Event Type
    Malfunction
    Date Received
    August 3, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 23, 2015
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSUMER'S ALLEGED DEFICIENCY (HIGH READINGS) COULD NOT BE CONFIRMED. ALTHOUGH THE REPORTED RESULTS WERE FOUND IN THE MEMORY OF THE RETURNED DEVICE, FAILURE ANALYSIS OF THE RETURNED PRODUCTS (BLOOD GLUCOSE MONITOR AND TEST STRIPS) REVEALED THAT THE NOVA MAX LINK GLUCOSE MONITORING SYSTEM PERFORMED WITHIN SPECIFICATION. VISUAL AS WELL AS CHEMICAL EVALUATION (WITH CONTROL SOLUTION AND BLOOD) WAS NOT ABLE TO REPLICATE THE ALLEGED ISSUE.

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS HAVE BEEN RETURNED FOR EVAL. TEST STRIP LOT # 102021214287 EXPIRATION DATE: 10/2016 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. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CONSUMER CALLED INTO CUSTOMER CARE CONCERNED ABOUT HIS HIGH BLOOD GLUCOSE READINGS. ACCORDING TO THE CONSUMER ON (B)(6) 2015 HE CONTINUED TO ADMINISTER UNK AMOUNTS OF INSULIN BASED ON MULTIPLE HIGH READINGS THROUGHOUT THE MORNING ON HIS BLOOD GLUCOSE METER. THE CONSUMER REPORTED THAT HIS BLOOD SUGAR LEVELS DID NOT DROP AFTER THE INSULIN DOSES WERE ADMINISTERED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505431 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020214287

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK