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	650	650
High Test Results	500	500
Incorrect, Inadequate or Imprecise Result or Readings	199	202
Low Test Results	166	166
Non Reproducible Results	123	124
Patient Data Problem	9	9
Labelling, Instructions for Use or Training Problem	9	9
Device Sensing Problem	7	7
Material Twisted/Bent	7	7
Insufficient Information	6	6
Output Problem	5	5
Unintended Movement	5	5
Component Missing	5	5
Inaccurate Information	4	4
Manufacturing, Packaging or Shipping Problem	4	6
Incorrect Measurement	4	4
Adverse Event Without Identified Device or Use Problem	4	4
No Device Output	3	3
Loss of or Failure to Bond	3	3
Device Displays Incorrect Message	3	5
Communication or Transmission Problem	3	3
No Apparent Adverse Event	3	3
Contamination /Decontamination Problem	3	3
Shipping Damage or Problem	3	3
Display or Visual Feedback Problem	2	2
Illegible Information	2	3
Failure to Fire	2	2
Low Readings	2	2
Product Quality Problem	2	4
Calibration Problem	2	2
Use of Device Problem	2	2
Failure to Power Up	2	2
High Readings	2	2
Material Integrity Problem	2	2
Defective Device	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
Device Difficult to Program or Calibrate	1	1
Imprecision	1	1
Expiration Date Error	1	1
Defective Component	1	1
Failure to Sense	1	1
Failure to Transmit Record	1	1
Device Markings/Labelling Problem	1	3
Appropriate Term/Code Not Available	1	1
Image Display Error/Artifact	1	1
Mechanical Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1421	1423
Hyperglycemia	74	74
Hypoglycemia	71	71
No Consequences Or Impact To Patient	41	41
Loss of consciousness	25	25
Dizziness	15	15
Shaking/Tremors	11	11
Fatigue	9	9
Diabetic Ketoacidosis	9	9
Insufficient Information	9	13
Diaphoresis	8	8
Headache	6	6
Confusion/ Disorientation	3	3
Vomiting	3	3
Coma	3	3
Abdominal Pain	2	2
Skin Inflammation/ Irritation	2	2
Numbness	2	2
Blurred Vision	2	2
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Dry Mouth	1	1
Nausea	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Tachycardia	1	1
Polydipsia	1	1
Aphonia	1	1
Low Blood Pressure/ Hypotension	1	1
Urinary Tract Infection	1	1
Distress	1	1

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