BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3772774 · Received March 3, 2014

    Report

    Report Number
    3004193489-2014-00010
    Event Type
    Other
    Date Received
    March 3, 2014
    Date of Event
    July 31, 2013
    Report Date
    February 6, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013 - NOVA BIOMEDICAL DECIDED TO VOLUNTARILY RECALL THIS LOT OF TEST STRIPS. LOCAL FDA OFFICE NOTIFIED. RELATED MEDWATCH REPORT: 3004193489-2014-00009. TEST STRIP LOT # 1020412255, EXPIRATION DATE: 09/2014, CONTROL SOLUTION LOT: DID NOT HAVE ANY CONTROLS. 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 ON (B)(6) 2014 THAT A CONSUMER, "HAD TO HAVE MEDICAL INTERVENTION TWICE WITHIN A WEEK OF EACH OTHER IN (B)(6) 2013. CONSUMER BELIEVES THIS HAPPENED DUE TO HER USING RECALLED NOVA MAX TEST STRIPS." DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED WHEN THE EMTS ARRIVED, THEY PERFORMED A GLUCOSE TEST GETTING A RESULT OF 50 MG/DL USING THEIR UNKNOWN METER BRAND. CONSUMER WAS TREATED WITH IV GLUCOSE TO STABILIZE HER BLOOD GLUCOSE LEVEL. THE METER WILL BE RETURNED FOR EVALUATION, HOWEVER, THE TEST STRIPS WERE RETURNED (B)(6) 2013 AS PART OF THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128428 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020412255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention