BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2598561 · Received May 31, 2012

    Report

    Report Number
    1826988-2012-00308
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND LOT# OF CONTOUR TEST STRIPS WAS RETURNED FOR EVALUATION: PRODUCT CODE NOT PROVIDED, LOT# 1DC3A06A, EXP. DATE 04/30/2013, MANUFACTURE DATE 04/2011, 510 (K) K062058. LOT# 1DC3A02A READ 317MG/DL HIGH OUT OF SPEC. LOT# IDC3A06A READ 377MG/DL HIGH OUT OF SPEC.

    Description of Event or Problem · 1

    ADVOCATE ALLEGED THAT CUSTOMER WAS NOT GETTING A READING AT ALL WITH HER CONTOUR METER. NO ADVERSE EVENTS ALLEGED. THE COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED AT THE TIME OF THE CALL, BUT THE TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 1DC3A02A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK