BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1141367 · Received August 22, 2008

    Report

    Report Number
    3004193489-2008-00538
    Event Type
    Other
    Date Received
    August 22, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 22, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 405 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN. CONSUMER REPORTS THAT HE WOKE UP AROUND 1:00AM AND TESTED HIMSELF AGAIN GETTING A 279 MG/DL. THE CONSUMER DID NOT BELIEVE THAT READING TO BE AN ACCURATE READING. HE THEN TESTED HIMSELF ON ANOTHER NOVA BIOMEDICAL METER GETTING A RESULT OF 69 MG/DL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST THEIR TEST STRIPS AND TRANSFERS TEST STRIPS FROM VIAL TO VIAL WHICH MAY CONTRIBUTE TO A LOSS OF INTEGRITY OF HIS TEST STRIPS. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK