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
Erratic Results	449	449
High Test Results	437	437
Incorrect, Inadequate or Imprecise Result or Readings	216	219
Non Reproducible Results	148	149
Low Test Results	141	141
Labelling, Instructions for Use or Training Problem	8	8
Incorrect Measurement	7	7
Material Twisted/Bent	7	7
Device Sensing Problem	6	6
Unintended Movement	5	5
Insufficient Information	5	5
Patient Data Problem	5	5
Component Missing	5	5
Output Problem	4	4
Inaccurate Information	4	4
Manufacturing, Packaging or Shipping Problem	4	6
Adverse Event Without Identified Device or Use Problem	4	4
Loss of or Failure to Bond	3	3
Device Displays Incorrect Message	3	5
No Apparent Adverse Event	3	3
Defective Device	3	3
Contamination /Decontamination Problem	3	3
Shipping Damage or Problem	3	3
No Device Output	2	2
Display or Visual Feedback Problem	2	2
Illegible Information	2	3
Failure to Fire	2	2
Low Readings	2	2
Calibration Problem	2	2
Use of Device Problem	2	2
Failure to Power Up	2	2
Material Integrity Problem	2	2
Display Difficult to Read	2	2
Incomplete or Missing Packaging	2	2
Activation, Positioning or Separation Problem	2	2
Circuit Failure	2	2
Application Program Problem: Dose Calculation Error	1	1
Imprecision	1	1
High Readings	1	1
Device Difficult to Program or Calibrate	1	1
Expiration Date Error	1	1
Defective Component	1	1
Product Quality Problem	1	3
Failure to Sense	1	1
Failure to Transmit Record	1	1
Image Display Error/Artifact	1	1
Device Markings/Labelling Problem	1	3
Appropriate Term/Code Not Available	1	1
Communication or Transmission Problem	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1089	1091
No Consequences Or Impact To Patient	167	167
Hyperglycemia	57	57
Hypoglycemia	54	54
Loss of consciousness	20	20
Insufficient Information	9	13
Shaking/Tremors	9	9
Fatigue	7	7
Diabetic Ketoacidosis	7	7
Dizziness	6	6
Diaphoresis	4	4
Vomiting	3	3
Coma	3	3
Headache	3	3
Abdominal Pain	2	2
Skin Inflammation/ Irritation	2	2
No Known Impact Or Consequence To Patient	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Syncope/Fainting	1	1
Skin Irritation	1	1
Nausea	1	1
Confusion/ Disorientation	1	1
Numbness	1	1
Tachycardia	1	1
Aphonia	1	1
Blurred Vision	1	1
Low Blood Pressure/ Hypotension	1	1
Distress	1	1
Urinary Tract Infection	1	1

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