BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVA MAX

    MDR report key: 1977753 · Received January 28, 2011

    Report

    Report Number
    MW5019213
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    November 20, 2010
    Report Date
    January 28, 2011
    Manufacturer
    NOVA BIOMEDICAL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WOULD LIKE TO BRING TO YOUR ATTENTION FALSE READINGS BY YOUR NOVA MAX GLUCOSE TEST STRIPS. LOT NUMBER 1020210181 EXP DATE 2012-06, PART NUMBER: 43437. SAT (B)(6) 2010: I SPENT 6 HOURS GIVING MYSELF 110 UNITS OF INSULIN AS A RESULT OF INACCURATE TEST STRIP READINGS. I ENDED UP IN THE EMERGENCY ROOM WITH A SUGAR LEVEL OF 24, COMPLETELY INCOHERENT AND ON THE VERGE OF A DIABETIC COMA. ONCE THE DOCTORS REVIVED AND STABILIZED ME, WE COMPARED SUGAR LEVELS BETWEEN BY MACHINE WITH YOUR TEST STRIPS AND THE HOSPITAL'S MACHINES. THE TEST STRIPS SHOWED MY SUGAR LEVELS RANGING FROM 555-HIGH WHEN COMPARED TO THE EMERGENCY ROOM MACHINES READINGS OF 140. THIS SITUATION NEARLY COST ME MY LIFE AND ONCE I CHANGED MY TEST STRIPS, I FINALLY OBTAINED ACCURATE READINGS AND WAS DISCHARGED FROM THE HOSPITAL. DATES OF USE: (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE TEST STRIPS, 50 NBW NOVA BIOMEDICAL 1020210181

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| L