BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1701343 · Received May 19, 2010

    Report

    Report Number
    2248721-2010-00084
    Event Type
    Malfunction
    Date Received
    May 19, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 19, 2010
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Product Code
    GKR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MFR AWAITING PRODUCT RETURN FOR EVAL.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS: INCONSISTENT RESULTS ON THE HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM (HGB PRO) VS AN UNSPECIFIED LAB INSTRUMENT. ON (B)(6) 2010, HGB PRO 5.2 G/DL VS UNSPECIFIED LAB SYSTEM 7.3 G/DL. TARGET RANGE IS 12.5G/DL - 17G/DL. PT WAS SENT TO THE HOSPITAL AND IS CURRENTLY OKAY. NO ADVERSE REACTIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE GKR INTERNATIONAL TECHNIDYNE CORP. HGB PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other