BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 354961 · Received September 27, 2001

    Report

    Report Number
    1810909-2001-00081
    Event Type
    Malfunction
    Date Received
    September 27, 2001
    Date of Event
    September 2, 2001
    Report Date
    September 27, 2001
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT WHEN CUSTOMER USED EXCEL OFF BRAND REAGENT STRIPS CUSTOMER WOULD RECEIVE ERRATIC RESULTS. EXAMPLES WERE 240, 206, AND 121 MG/DL. THESE TESTS WERE CONSECUTIVE. WHILE ON THE PHONE A REVIEW OF THE SYSTEM OPERATION WAS CONDUCTED. ELECTRONIC CHECKS WERE SATISFACTORY. THE CUSTOMER WAS INFORMED THAT BAYER DOES NOT PROVIDE OR SUPPORT THE USE OF AN OFF BRAND REAGENT. THE COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43919 GLUCOMETER ELITE 4 BASIC BLOOD GLUCOSE METER NBW ARKRAY, INC. 3901N *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN