BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1030589 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00378
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT HAVE HIS TESTING SUPPLIES WITH HIM AT THE TIME OF THE CALL, SO IT WAS NOT POSSIBLE TO GATHER PRODUCT CODES OR LOT/SERIAL NUMBERS. IT'S NOT POSSIBLE TO DETERMINE THE MFR DATE WITHOUT THAT INFO.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 226 MG/DL. THE CUSTOMER DID NOT HAVE HIS TESTING SUPPLIES WITH HIM AT THE TIME OF THE CALL, SO IT WAS NOT POSSIBLE TO GATHER ANY PRODUCT INFO. THE NORMAL CONTROL RANGE FOR CONTOUR TEST STRIPS SHOULD BE AROUND 100-140 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK