BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 694601 · Received March 31, 2006

    Report

    Report Number
    1826988-2006-00331
    Event Type
    Malfunction
    Date Received
    March 31, 2006
    Date of Event
    March 22, 2006
    Report Date
    March 22, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONTACT STATED THAT THE CUSTOMER HAD A READING OF 11.5. SHE WANTED TO KNOW HOW TO CONVERTY IT TO MG/DL. THE CUSTOMER RAN OUT OF STRIPS AND TOOL 3 READINGS USING AN OLD METER BEFORE IT WAS DISCOVERED THE METER WAS SET IN MMOL/L. NO MEDICATION ADJUSTMENT WERE MADE AND NO ADVERSE EVENTS WERE ALLEGED. THE CONTACT DID NOT KNOW WHAT TYPE OF METER THE CUSTOMER USED AND SHE WOULD NOT GIVE ANU INFORMATION ABOUT THE PT. THE CONTACT WAS SATISFIED AND WILL CALL BACK IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN