BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3530209 · Received December 6, 2013

    Report

    Report Number
    3004193489-2013-00137
    Event Type
    Other
    Date Received
    December 6, 2013
    Report Date
    September 12, 2013
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED MEDWATCH REPORTS: 3004193489-2013-00135, 00136. TEST STRIP LOT #1020213155, EXPIRATION DATE: 06/2015, CONTROL SOLUTION RANGE: 82-127 MG/DL. 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 ON (B)(6) 2013, "...THAT THE CONSUMER WAS FOUND BY HER (B)(6) MOTHER PASSED OUT ON THE FLOOR ON THREE OCCASIONS." IT IS UNKNOWN IF THERE WAS ANY MEDICAL OR EMERGENCY FOOT INTERVENTION FOR TWO OF THREE EVENTS. ON (B)(6) 2013 EMTS TRANSPORTED THE CONSUMER TO THE HOSPITAL. THE CONSUMER STATED, '...I DON'T RECALL SPECIFIC DETAILS OF THE INCIDENTS." THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634189 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020213155

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R