BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 680020 · Received January 31, 2006

    Report

    Report Number
    MW1037838
    Event Type
    Malfunction
    Date Received
    January 31, 2006
    Date of Event
    January 1, 2006
    Report Date
    January 31, 2006
    Manufacturer
    AKERS BIOTECH
    Product Code
    JIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS DEVICE WAS PURCHASED TO BE USED IN MEASURING LITHIUM LEVELS IN THE BLOOD AND HENCE ITS CLEARANCE BY THE KIDNEYS. DURING USE IT WAS FOUND THAT IT GAVE INACCURATELY HIGHER RESULT THAN NORMAL ESPECIALLY WHEN USED IN HIGH ALTITUDE AND WHEN THE COMPLAINT WAS LODGED WITH THE CO IT WAS A SUPRISE. BESIDES THE MORE THE RED BLOOD CELLS THE LESS THE AMOUNT OF LITHIUM THAT SEPARATES. THE REPLACEMENT HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * INSTAREAD LITHIUM JIH AKERS BIOTECH * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *