BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE

    MDR report key: 185580 · Received August 20, 1998

    Report

    Report Number
    1810909-1998-00006
    Event Type
    Malfunction
    Date Received
    August 20, 1998
    Date of Event
    March 22, 1998
    Report Date
    August 20, 1998
    Manufacturer
    KDK CORP.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATED THAT HIS GLUCOMETER ELITE WAS READING LOW DURING A RECENT COMPARISON. HE STATES THAT HIS DOCTORS METER READ 430 MG/DL WHILE HIS ELITE READ 66 MG/DL. CONTROL SOLUTION TESTING AND CHECK PADDLE RESULTS WERE SATISFACTORY. ON 03/22/98 THE CUSTOMER HAD BEEN VOMITING AND TOOK SOME PEPTO-BISNOL. NOT FEELING WELL HE WENT TO HIS DOCTOR WHERE THE ABOVE READINGS WERE MADE. HIS DOCTOR SENT HIM TO THE EMERGENCY ROOM FOR AN IV. THE CUSTOMER WAS IN THE EMERGENCY ROOM FOR 3 HOURS. AT THE EMERGENCY ROOM HIS ELITE READ A 101 MG/DL WHILE THE HOSPITAL METER GAVE A 263 MG/DL. THE CUSTOMER WAS RELEASED AND A REQUEST WAS MADE TO RETURN THE SYSTEM FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE BLOOD GLUCOSE METER CGA KDK CORP. 3901A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN