BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3772776 · Received March 3, 2014

    Report

    Report Number
    3004193489-2014-00008
    Event Type
    Other
    Date Received
    March 3, 2014
    Date of Event
    February 1, 2014
    Report Date
    February 4, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020213252, EXPIRATION DATE: 09/2015; CONTROL SOLUTION, LOT # 1030313121 RANGE: 82-127 MG/DL. 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER "WAS RUSHED O THE HOSPITAL LAST FRIDAY NIGHT FOR A LOW BLOOD SUGAR. CONSUMER BELIEVES THIS WAS DUE TO INACCURATE READINGS HE REC'D ON HIS NOVA MAX LINK METER." THE CONSUMER REPORTED WHEN HE ARRIVED AT THE HOSPITAL A BLOOD GLUCOSE TEST WAS PERFORMED ON AN UNKNOWN HOSPITAL METER GETTING A RESULT OF 32 MG/DL. THE CONSUMER REPORTED PERFORMING A BLOOD GLUCOSE TEST ON HIS GLUCOSE METER AT 7PM ON (B)(6) 2014 GETTING A RESULT OF 207 MG/DL. IT WAS NOT REPORTED BY THE CONSUMER IF ANY INSULIN OR ORAL MEDICATIONS WERE ADMINISTERED BASED ON THAT RESULT. DURING THE CALL TO CUSTOMER SUPPORT, THE CONSUMER CONTROL TESTED THEIR TEST STRIPS WHEN THEY WERE OPENED AND THE TEST STRIPS CONTROL SOLUTION FELL INTO RANGE. ANOTHER CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING SHOWING THE TEST STRIPS TO FALL IN RANGE. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128435 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020213252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention