BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 4096750 · Received September 5, 2014

    Report

    Report Number
    3004193489-2014-00082
    Event Type
    Other
    Date Received
    September 5, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 25, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT NUMBER 1020814091 EXPIRATION DATE: 04/2016. CONTROL SOLUTION LOT NUMBER NONE. 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 EVALUATION. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT THE CONSUMER, "...WAS RUSHED TO THE HOSPITAL DUE TO HIS NOVA MAX LINK THAT, WAS GIVING HIM HIGH BLOOD GLUCOSE READINGS WHICH CAUSED HIS PUMP TO GIVE HIM TOO MUCH INSULIN..." ACCORDING TO THE CONSUMER HIS NEIGHBOR FOUND HIM ON THE KITCHEN FLOOR UNRESPONSIVE AND CALLED FOR MEDICAL INTERVENTION. ACCORDING TO THE CONSUMER, WHEN THE EMTS ARRIVED THEY PERFORMED A BLOOD GLUCOSE TEST USING THEIR UNKNOWN BRAND GETTING A RESULT OF "...7 MG/DL..." THE CONSUMER STATED WHILE HE WAS BEING TRANSPORTED TO THE HOSPITAL, HE WAS GIVEN IV BY THE EMTS. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE AND THE CONSUMER DECLINED TO PERFORM A CONTROL SOLUTION TEST WHILE ON THE PHONE WITH CUSTOMER SUPPORT. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545982 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020814091

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R