BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1021829 · Received March 27, 2008

    Report

    Report Number
    1826988-2008-00322
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A NURSE CALLED ON BEHALF OF THE CUSTOMER. SHE STATED THE CUSTOMER'S GLUCOSE WAS TESTED USING HIS CONTOUR METER AND THE READING WAS 489 MG/DL. THE CUSTOMER'S GLUCOSE WAS RETESTED USING ANOTHER METER AND THAT READING WAS 115 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. A CONTROL TEST PERFORMED WHILE TROUBLESHOOTING WAS WITHIN THE NORMAL CONTROL RANGE. THE CUSTOMER ONLY HAD ONE TEST STRIP LEFT, SO NO PROD 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 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK