TPLC - Total Product Life Cycle

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Device	glucose dehydrogenase, glucose
Product Code	LFR
Regulation Number	862.1345
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	181	181
Incorrect, Inadequate or Imprecise Result or Readings	171	171
Non Reproducible Results	144	144
Low Test Results	86	86
Incorrect Or Inadequate Test Results	11	11
Material Twisted/Bent	8	8
Device Displays Incorrect Message	7	7
Unintended Movement	5	5
Inaccurate Information	4	4
Incorrect Measurement	4	4
Loss of or Failure to Bond	3	3
Defective Device	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Failure to Fire	2	2
Activation, Positioning or Separation Problem	2	2
Device Markings/Labelling Problem	2	2
Failure to Power Up	2	2
Defective Component	2	2
High Readings	2	2
Nonstandard Device	1	1
Loss of Power	1	1
Failure to Sense	1	1
Use of Device Problem	1	1
Premature Activation	1	1
Device Difficult to Program or Calibrate	1	1
Product Quality Problem	1	1
Unable to Obtain Readings	1	1
Break	1	1
Circuit Failure	1	1
False Reading From Device Non-Compliance	1	1
Image Display Error/Artifact	1	1
Device Contamination with Chemical or Other Material	1	1
Battery Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Illegible Information	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	332	332
No Clinical Signs, Symptoms or Conditions	214	214
No Known Impact Or Consequence To Patient	42	42
Hyperglycemia	15	15
Insufficient Information	7	7
No Information	5	5
Hypoglycemia	5	5
Coma	2	2
Sweating	2	2
Dizziness	2	2
Shaking/Tremors	1	1
Device Embedded In Tissue or Plaque	1	1
Aphonia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Loss of consciousness	1	1
Diabetic Ketoacidosis	1	1
Low Blood Pressure/ Hypotension	1	1
Skin Irritation	1	1
Weakness	1	1