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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device glucose dehydrogenase, glucose
Regulation Description Glucose test system.
Product CodeLFR
Regulation Number 862.1345
Device Class 2

MDR Year MDR Reports MDR Events
2020 132 132
2021 164 164
2022 101 101
2023 103 103
2024 168 168
2025 61 61

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 227 227
Incorrect, Inadequate or Imprecise Result or Readings 207 207
Non Reproducible Results 108 108
Erratic Results 85 85
Low Test Results 82 82
Material Twisted/Bent 7 7
Incorrect Measurement 6 6
Unintended Movement 5 5
Component Missing 5 5
Inaccurate Information 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Output Problem 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Loss of or Failure to Bond 3 3
Device Displays Incorrect Message 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
No Apparent Adverse Event 3 3
Circuit Failure 3 3
Shipping Damage or Problem 3 3
Failure to Fire 2 2
Display or Visual Feedback Problem 2 2
Incomplete or Missing Packaging 2 2
Activation, Positioning or Separation Problem 2 2
Material Integrity Problem 2 2
Failure to Power Up 2 2
Illegible Information 2 2
Imprecision 1 1
Low Readings 1 1
Use of Device Problem 1 1
Failure to Sense 1 1
High Readings 1 1
Display Difficult to Read 1 1
Calibration Problem 1 1
Defective Component 1 1
Device Difficult to Program or Calibrate 1 1
Image Display Error/Artifact 1 1
Insufficient Information 1 1
Product Quality Problem 1 1
Device Markings/Labelling Problem 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 500 500
No Consequences Or Impact To Patient 167 167
Hyperglycemia 22 22
Hypoglycemia 19 19
Insufficient Information 9 9
Loss of consciousness 4 4
Diabetic Ketoacidosis 4 4
Coma 3 3
Vomiting 3 3
Shaking/Tremors 3 3
No Known Impact Or Consequence To Patient 2 2
Confusion/ Disorientation 1 1
Tachycardia 1 1
Low Blood Pressure/ Hypotension 1 1
Skin Irritation 1 1
Aphonia 1 1
Headache 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fatigue 1 1
Abdominal Pain 1 1

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