Health / Medical Topics

    Incorrect Instruction for Medical Device Use

    Issue associated with inaccuracies in any written, printed, or graphic matter that is affixed to a medical device or its containers, wrappers; with any matter that accompanies a medical device including verbal instructions related to identification, technical description and use of the medical device provided by the device manufacturers. (Food and Drug Administration)




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    Issue associated with device failure and malfunction when device does not display adequate results or have proper display.
    The device software was found to implement an incorrect sequence of steps for a specific computation.
    The device software was found to contain errors in specifying or manipulating data items.
    Issue associated with user's failure to process, service, or operate the device according to the manufacturer's recommendations or recognized best practices. …
    The wrong booklet was provided to an individual.

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