TPLC - Total Product Life Cycle

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Device	glucose dehydrogenase, glucose
Regulation Description	Glucose test system.
Product Code	LFR
Regulation Number	862.1345
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
High Test Results	332	332
Erratic Results	247	247
Incorrect, Inadequate or Imprecise Result or Readings	208	208
Non Reproducible Results	121	121
Low Test Results	108	108
Material Twisted/Bent	7	7
Incorrect Measurement	6	6
Device Sensing Problem	5	5
Unintended Movement	5	5
Component Missing	5	5
Inaccurate Information	4	4
Labelling, Instructions for Use or Training Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Loss of or Failure to Bond	3	3
Device Displays Incorrect Message	3	3
No Apparent Adverse Event	3	3
Shipping Damage or Problem	3	3
Contamination /Decontamination Problem	3	3
Defective Device	3	3
Insufficient Information	3	3
Output Problem	3	3
Circuit Failure	3	3
Failure to Power Up	2	2
Use of Device Problem	2	2
Material Integrity Problem	2	2
Failure to Fire	2	2
Display Difficult to Read	2	2
Illegible Information	2	2
Display or Visual Feedback Problem	2	2
Incomplete or Missing Packaging	2	2
Activation, Positioning or Separation Problem	2	2
High Readings	1	1
Defective Component	1	1
Imprecision	1	1
Failure to Sense	1	1
Application Program Problem: Dose Calculation Error	1	1
Device Difficult to Program or Calibrate	1	1
Calibration Problem	1	1
Device Markings/Labelling Problem	1	1
Image Display Error/Artifact	1	1
Communication or Transmission Problem	1	1
Product Quality Problem	1	1
Low Readings	1	1
Appropriate Term/Code Not Available	1	1
No Device Output	1	1
Premature Activation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	770	770
No Consequences Or Impact To Patient	167	167
Hyperglycemia	41	41
Hypoglycemia	37	37
Insufficient Information	9	9
Loss of consciousness	9	9
Shaking/Tremors	6	6
Diabetic Ketoacidosis	5	5
Dizziness	3	3
Vomiting	3	3
Coma	3	3
Fatigue	2	2
No Known Impact Or Consequence To Patient	2	2
Abdominal Pain	1	1
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Skin Irritation	1	1
Diaphoresis	1	1
Confusion/ Disorientation	1	1
Numbness	1	1
Tachycardia	1	1
Aphonia	1	1
Headache	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Roche Diabetes Care, Inc.	II	Aug-26-2021