TPLC - Total Product Life Cycle

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Device	method, enzymatic, glucose (urinary, non-quantitative)
Regulation Description	Urinary glucose (nonquantitative) test system.
Product Code	JIL
Regulation Number	862.1340
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Smoking	35	35
False Negative Result	32	32
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Non Reproducible Results	3	3
Device Difficult to Setup or Prepare	3	3
Incorrect Measurement	3	3
False Positive Result	3	3
Low Test Results	3	3
Patient Data Problem	2	2
Optical Problem	2	2
No Device Output	2	2
Device Markings/Labelling Problem	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
High Readings	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Missing Test Results	1	1
High Test Results	1	1
No Apparent Adverse Event	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	86	86
Insufficient Information	3	3
Distress	1	1