BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR NEXT

    MDR report key: 2673182 · Received July 27, 2012

    Report

    Report Number
    1826988-2012-00404
    Event Type
    Injury
    Date Received
    July 27, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 1, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND LOT# OF CONTOUR NEXT STRIPS WAS INVOLVED: LOT# 2CFEC03, EXP DATE 03/31/2014, MANUFACTURE DATE 01/01/2012, 510K K111268.

    Additional Manufacturer Narrative · 1

    THE INCORRECT LOT# OF 2CFEC03 WAS INITIALLY SUBMITTED. THE CORRECTED LOT# IS 2CFEC06, EXP DATE 09/30/2013, MANUFACTURE DATE 03/01/2012, THE CORRECT EXPIRATION DATE FOR LOT# 2CFEC52 IS 9/30/2013.

    Description of Event or Problem · 1

    AN ADVOCATE FROM (B)(6) CALLED ON BEHALF OF HER SON. THE CUSTOMER RECEIVED A BLOOD GLUCOSES READING OF 198MG/DL FROM HIS CONTOUR XT METER BUT HAD HYPOGLYCEMIC SYMPTOMS. HE THEN RETESTED WITH ANOTHER METER AND RECEIVED A RESULT OF "HYPO". HIS MOTHER GAVE HIM SOME HONEY, HE RETESTED WITH THE CONTOUR XT AND THE READING WAS 235MG/DL. THE EMS TEAM WAS CALLED AND TESTED HIS BLOOD GLUCOSE AT 33MG/DL. HE WAS HOSPITALIZED AND GIVEN MORE HONEY AND SUGAR WHILE BEING MONITORED. FURTHER INFORMATION ABOUT THE EVENT WAS NOT PROVIDED. IT WAS ASKED THAT STRIPS BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC NOT PROVIDED 2CFEC52

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization