BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT EZ

    MDR report key: 2874387 · Received December 14, 2012

    Report

    Report Number
    1826988-2012-00669
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K110587
    Removal / Correction Number
    Z-2482-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONTROL INFORMATION WAS NOT PROVIDED INITIALLY, BUT IT WAS RETURNED AND EVALUATED. BRAND NAME - CONTOUR NEXT. COMMON DEVICE NAME - QUALITY CONTROL MATERIAL, PRODUCT CODE JJX. PRODUCT INFORMATION - LOT# 2469, EXPIRATION DATE 11/30/2013. MANUFACTURE DATE - 05/01/2012.

    Additional Manufacturer Narrative · 1

    IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS. COMPLETE INITIAL REPORTER INFORMATION WAS NOT PROVIDED.MANUFACTURE DATE IS NOT ACCESSABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    SEE REMEDIAL ACTION AND CORRECTION/REMOVAL REPORTING NUMBER. THIS INFORMATION WAS NOT PROVIDED IN THE INITIAL REPORT.

    Description of Event or Problem · 1

    A (B)(6) SALES REP STATED A PHARMACIST RAN THE CONTROL TEST ON A CONTOUR NEXT EZ METER AND THE READING WAS HIGH OUT OF SPEC. AT 11.2MMOL/L. THE READING WAS NOT MARKED AS A CONTROL TEST IN THE METER. NO ADVERSE EVENT WAS ALLEGED. IT WAS NOT POSSIBLE TO PROVIDE THE CONTROL SOLUTION INFORMATION AND IT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NEXT EZ BLOOD GLUCOSE METER NBW ASCENSIA DIABETES CARE US INC. 7268

    Patients

    Seq Age Sex Outcome Treatment
    1