BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3772785 · Received March 3, 2014

    Report

    Report Number
    3004193489-2014-00013
    Event Type
    Other
    Date Received
    March 3, 2014
    Report Date
    January 7, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 - NOVA BIOMEDICAL DECIDED TO VOLUNTARILY RECALL THIS LOT OF TEST STRIPS. LOCAL FDA OFFICE NOTIFIED. TEST STRIP LOT # 1020412341, EXP DATE: 12/2014. TEST STRIP LOT # 1020213074, EXP DATE: 03/2015. CONTROL SOLUTION LOT: UNK. 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 FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    INFO RECEIVED ON (B)(4) 2013 FROM NOVA BIOMEDICAL COUNSEL THAT A CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT AFTER INSULIN ADMINISTRATION. NO OTHER INFO IS FORTHCOMING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128436 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020412341

    Patients

    Seq Age Sex Outcome Treatment
    1