BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 2874504 · Received December 14, 2012

    Report

    Report Number
    1826988-2012-00650
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MODEL # WAS NOT PROVIDED. INITIAL REPORTER PHONE AND ADDRESS WERE NOT PROVIDED. IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS

    Additional Manufacturer Narrative · 1

    STRIP INFORMATION WAS NOT INITIALLY PROVIDED. CONTOUR NEXT TEST STRIP: PRODUCT INFORMATION - MODEL NUMBER NOT PROVIDED, LOT# 2CFEC51, EXP DATE 9/30/2013, MANUFACTURE DATE 03/01/2012, 510K - K111268. CONTOUR TEST STRIPS: PRODUCT INFORMATION - MODEL NUMBER NOT PROVIDED, LOT# 1MC3A05. EXP DATE 12/31/2013, MANUFACTURE DATE 12/01/2011.

    Description of Event or Problem · 1

    A (B)(6) CUSTOMER RAN HIS BLOOD GLUCOSE TEST ON CONTOUR USB AND RECEIVED A READING OF 93MG/DL. HE RE-TESTED ON CONTOUR XT AND RECEIVED A READING BETWEEN 172-174MG/DL. THE DIFFERENCE BETWEEN THE READINGS FELL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. STRIP INFORMATION WAS NOT PROVIDED BUT METER INFORMATION WAS GIVEN. NO ADVERSE EVENT WAS ALLEGED. IT WAS ASKED THAT THE STRIPS BE RETURNED FOR EVALUATION. THE PRODUCT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR USB BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1