BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA ELITE BASIC

    MDR report key: 1082803 · Received July 24, 2008

    Report

    Report Number
    1826988-2008-00801
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE NIGHT SHIFT NURSE AT A NURSING HOME TESTED A PATIENT'S GLUCOSE, AND RECEIVED READINGS OF 124 AND 128 MG/DL USING THE FACILITY'S ELITE BASIC METER. PARAMEDICS WERE CALLED, AND THEY TESTED THE PATIENT'S BLOOD GLUCOSE AT 40 MG/DL USING THEIR METER. NO OTHER INFORMATION WAS PROVIDED ABOUT THE EVENT, BUT IT'S ASSUMED THE PATIENT WAS TREATED WITH GLUCOSE. CONTROL TESTS PERFORMED USING LOW AND HIGH CONTROL SOLUTIONS SHOWED THE METER AND REAGENT TO BE OPERATING AS DESIGNED. ATTEMPTS MADE TO CONTACT THE NURSING HOME FOR MORE INFO HAVE NOT BEEN SUCCESSFUL. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA ELITE BASIC BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 3885G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention