BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3772251 · Received April 1, 2014

    Report

    Report Number
    3004193489-2014-00022
    Event Type
    Other
    Date Received
    April 1, 2014
    Report Date
    March 21, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 26, 2013 NOVA BIOMEDICAL DECIDED TO VOLUNTARILY RECALL THIS LOT OF TEST STRIPS. LOCAL FDA OFFICE NOTIFIED. TEST STRIP LOT NUMBER: 1020411347 EXPIRATION DATE: 12/01/2013 CONTROL SOLUTION LOT: CONSUMER DIDN'T HAVE ANY CS. 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 BIOMED AWAITS THE RETURN OF THE DEVICE FOR EVAL. 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) 2014 BY THE CONSUMER "THAT, SOMETIME IN (B)(6) 2013 DUE TO INACCURATE READINGS HE ADMINISTERED TOO MUCH INSULIN AND HE WAS RUSHED TO THE HOSPITAL BY HIS FAMILY." THE CONSUMER WAS NOT ABLE TO PROVIDE ANY OF THE INACCURATE READING RESULTS NOR COULD HE PROVIDE ANY FURTHER INFO REGARDING THE REPORTED EVENT. THE METER WILL BE RETURNED FOR EVAL. THE TEST STRIPS WERE EITHER DISCARDED OR USED UP BY THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196645 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS NA 1020411347

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention