BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1051756 · Received May 23, 2008

    Report

    Report Number
    1826988-2008-00544
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 26, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THAT THE CUSTOMER TESTED HIS BLOOD GLUCOSE ONE EVENING AND REC'D A READING OF 458 MG/DL. SHE ALLEGED THE READING WAS TOO HIGH, SO SHE GAVE HIM 15 UNITS OF INSULIN. AROUND MIDNIGHT, THE CUSTOMER PASSED OUT. THE ADVOCATE TESTED HIS GLUCOSE AROUND 2:00 AM AND RECEIVED A READING OF 46 MG/DL. SHE GAVE HIM SOME SUGAR AND RETESTED 15 MINUTES LATER. THE READING WAS 39 MG/DL. THE ADVOCATE THEN CALLED AN AMBULANCE. PARAMEDICS TESTED THE CUSTOMER'S GLUCOSE AT 56 MG/DL USING THEIR METER. THEY TREATED THE CUSTOMER WITH IV GLUCOSE, BUT HE WAS NOT TAKEN TO THE HOSP. THE TEST STRIPS AND METER ARE TO BE RETURNED FOR EVAL. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC NOT PROVIDED 7KC3D02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK