BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3960581 · Received July 16, 2014

    Report

    Report Number
    3004193489-2014-00059
    Event Type
    Other
    Date Received
    July 16, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 7, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #: UNK. CONTROL SOLUTION LOT #: NONE. PER THE INSTRUCTIONS FOR USE, UNDER THE STORAGE AND HANDLING SECTION ON THE PACKAGE INSERT FOR THE NOVA MAX TEST STRIPS. - TEST STRIPS SHOULD BE STORED IN THE ORIGINAL VIAL. NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER CONTINUED TO ADMINISTER INSULIN BASED ON MULTIPLE HIGH READINGS ON THEIR BLOOD GLUCOSE METER. THE CONSUMER CONTINUED TO ALTERNATE FOOD AND INSULIN ADMINISTRATION TO OFFSET HER BLOOD GLUCOSE READINGS WHICH REQUIRED MEDICAL INTERVENTION. WHEN THE EMTS ARRIVED THEY PERFORMED A BLOOD GLUCOSE TEST ON THEIR UNK BRAND OF METER GETTING A RESULT OF 53 MG/DL. THE CONSUMER WAS TRANSPORTED TO THE HOSP DUE TO AN IRREGULAR HEART BEAT AND NOT BECAUSE OF HIS BLOOD GLUCOSE READING. 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. IT WAS ALSO REVEALED THAT THE CONSUMER TRANSFERS TEST STRIPS FROM ONE VIAL TO ANOTHER, 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. THE METER WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415932 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention