BEUDAMED
    FDA Adverse Event Other Summary report: N

    GLUCOMETER ELITE 4 BASIC

    MDR report key: 450770 · Received March 19, 2003

    Report

    Report Number
    1810909-2003-00134
    Event Type
    Other
    Date Received
    March 19, 2003
    Date of Event
    February 19, 2003
    Report Date
    March 18, 2003
    Manufacturer
    ARKRAY, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS USED EXCEL OFF BRAND REAGENT STRIPS WITH READING OF 140-159 MG/DL. WHEN THEY USE ELITE TEST STRIPS, THE RESULTS ARE EITHER TOO HIGH OR TOO LOW. FOR EXAMPLE, THEY HAVE HAD A READING AS HIGH AS 249 MG/DL AND A READING AS LOW AS "LO". THE DIFFERENCE IN THESE READINGS MAY BE CLINICALLY SIGNIFICANT. WHILE ON THE PHONE, AN OFFER WAS MADE TO TROUBLESHOOT THE METER. IT WAS ALSO EXPLAINED THAT BAYER DOES NOT PROVIDE OR SUPPORT THE USE OF OFF BRAND REAGENT. THE METER WAS FOUND TO BE FUNCTIONING WITHIN SPECIFICATION. ALSO, PROPER TECHNIQUE WAS REVIEWED WITH THE CUSTOMER. IT WAS FOUND THAT THE CUSTOMER MAY NOT HAVE BEEN APPLYING THE BLOOD TO THE TEST STRIP PROPERLY. THE CUSTOMER HAS BEEN INVITED TO CONTACT THE 24/7 CUSTOMER SERVICE LINE SHOULD ANY PROBLEMS OR QUESTIONS ARISE. THIS COMPLAINT IS CONSIDERED CLOSED FOR PURPOSES OF MDR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other