BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 2223343 · Received August 16, 2011

    Report

    Report Number
    1826988-2011-00477
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE EITHER METER SERIAL NUMBER SO, IT WAS NOT POSSIBLE TO DETERMINE A MFR DATE.

    Description of Event or Problem · 1

    A HOSP NURSE CONTACTED CUSTOMER SERVICE VIA EMAIL. SHE STATED THAT SHE TESTED HER BLOOD GLUCOSE USING CONTOUR USB AND CONTOUR METERS. THE CONTOUR USB READ 21 MG/DL, WHILE THE CONTOUR READ 127 MG/DL. SHE ALSO STATED THAT A PT MENTIONED RECEIVING A CONTOUR USB READING OF 225 MG/DL, WHILE HIS CONTOUR METER READ 108 MG/DL. THE DIFFERENCE BETWEEN BOTH SETS OF COMPARISON READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. NO PRODUCT WILL BE RETURNED AT THIS TIME. REPLACEMENT METERS WERE SENT TO THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR USB NBW BAYER HEALTHCARE, LLC 7390 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK