BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTAREAD LITHIUM SYSTEM

    MDR report key: 672100 · Received January 26, 2006

    Report

    Report Number
    MW1037847
    Event Type
    Injury
    Date Received
    January 26, 2006
    Date of Event
    January 25, 2006
    Report Date
    January 26, 2006
    Manufacturer
    AKERS BIOSCIENCES INC
    Product Code
    JIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR PURCHASED A CLIA WAIVED INSTAREAD LITHIUM SYSTEM AFTER READING THE LITERATURE WHICH STATED THE SYSTEM COULD TEST LITHIUM LEVELS IN WHOLE BLOOD AFTER EITHER FINGERSTICK OR BLOOD FROM AN EDTA TUBE. AS A WAY OF ASSURING THAT THE TEST WAS RELIABLE, RPTR ALSO SENT SAMPLES TO REGULAR LABORATORY. WHEN DOING THIS RPTR NOTICED THAT THERE WAS SOMETIMES UP TO 0.5 MEQ/L -HIGHER- DIFFERENCE IN THE LABORATORY METHOD, VS POINT-OF-CARE TEST. THE DIFFERENCES WERE NOT CONSISTENT ENOUGH THAT RPTR COULD NOT EXTRAPOLATE FROM THIS A METHOD TO "CORRECT" FOR THE VARIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTAREAD LITHIUM SYSTEM * JIH AKERS BIOSCIENCES INC * CA142A05

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability