BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3099538 · Received April 30, 2013

    Report

    Report Number
    3004193489-2013-00040
    Event Type
    Other
    Date Received
    April 30, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 25, 2013
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 A CONSUMER RECEIVED A RESULT OF 35 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER CONTACTED EMTS TO HAVE HER BLOOD GLUCOSE LEVEL TESTED AND ON THEIR UNKNOWN BRAND, THEY RECEIVED A RESULT OF 128 MG/DL. THE CONSUMER DID NOT TRUST THE RESULTS OF 128 MG/DL. THE CONSUMER DID NOT TRUST THE RESULTS AND TREATED HERSELF WITH A GLASS OF JUICE AND GRAPES TO HELP RAISE HER BLOOD GLUCOSE LEVEL. SHE CONTINUED TO HAVE ERRATIC RESULTS THROUGHOUT THE DAY. 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. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187030 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020212291

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention