Inadequate Instructions for Device Use Evaluation Result

Insufficient information on the labels or in the manuals related to a device's instructions for use e.g. steps that are difficult to follow or that are missing. (Food and Drug Administration)

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Inadequate Device Operator Training

Issue associate with facility not providing satisfactory initial and/or periodic user training covering operation of the device.

Inadequate Device Labeling Content Problem Evaluation Result

Invalid, incorrect, or inappropriate information on the labels (not including instructions for use) e.g. mislabeled contents or device labeling characteristics or package…

Inadequate Device Immunity Problem Evaluation Result

A device that lacks adequate immunity or capabilities to resist electromagnetic interference (EMI).

Inadequate Application Program User Interface Associated with Medical Device Problem

Issue associated with the means by which the operator and the equipment communicate or interact.

Inadequate

Not meeting a quantitative or qualitative measure necessary for a requirement.

Inactive Tyrosine-Protein Kinase 7

Inactive tyrosine-protein kinase 7 (1070 aa, ~118 kDa) is encoded by the human PTK7 gene. This protein is involved in both signal…