BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE 4 DATE

    MDR report key: 667865 · Received January 20, 2006

    Report

    Report Number
    1826988-2006-00028
    Event Type
    Malfunction
    Date Received
    January 20, 2006
    Date of Event
    January 10, 2006
    Report Date
    January 12, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER'S DAUGHTER STATES THAT HER FATHER'S READINGS HAVE BEEN ABNORMAL THIS WEEK--BOTH HIGHER AND LOWER. HIS NORMAL READINGS ARE 100-140MG/DL. HIS READINGS HAVE BEEN 184, 199, 233, 420, 88, 213. CUSTOMER SERVICE HAD THE CALLER CHECK THE MEMORY AND FOUND RESULTS OF 14.8, 18.4, 19.9, 23.3, 4.9, 17.6, 15.7 MMOL/L. THE CUSTOMER HDI NOT NOTICE THE DECIMAL POINT IN THE READINGS. CUSTOMER SERVICE HELPED THE CALLER SET THE METER BACK TO MG/DL. RESULTS IN MG/DL WERE 266, 332, 359, 213, 420, 88, 316, 283, 243MG/DL. CHECK TEST SHOWED THE METER WAS WORKING CORRECTLY. METER WAS CODED CORRECTLY TO F-5. CUSTOMER SERVICE DISCUSSED CORRECT TECHNIQUES. CUSTOMER PERFORMED TWO BLOOD TESTS AND VERIFIED PROPER FILL--RESULTS WERE 379 AND 390MG/DL. CUSTOMER SERVICE ADVISED THE CALLER TO CONTACT A DOCTOR WITH RESULTS 250+ OR -50MG/DL. CUSTOMER SERVICE ADVISED THE CUSTOMER TO RETURN THE METER AND WILL REPLACE WITH ANOTHER ELITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE 4 DATE BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 3901B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN