BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1130468 · Received August 20, 2008

    Report

    Report Number
    1826988-2008-00893
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND THE RETURNED REAGENT TO READ AN AVERAGE OF 14MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    A PHARMACIST CALLED ON BEHALF OF THE CUSTOMER. HE ALLEGED THAT THE CUSTOMER HAD RECEIVED OUT OF RANGE CONTROL TEST RESULTS. THE PHARMACIST PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 145 MG/DL. THE NORMAL CONTROL RANGE WAS 103-142 MG/DL. THE PHARMACIST ALSO STATED THAT THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 40 MG/DL AND WAS LIGHT HEADED AND DISORIENTED. THE PHARMACIST WAS UNABLE TO PROVIDE ANY MORE INFO ABOUT THE EVENT. THE TEST STRIPS WERE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS 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 7080D 7JC3B06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK