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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
Product CodeLFR
Regulation Number 862.1345
Device Class 2

MDR Year MDR Reports MDR Events
2019 108 108
2020 132 132
2021 164 164
2022 101 101
2023 103 103
2024 122 122

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 220 220
Incorrect, Inadequate or Imprecise Result or Readings 209 209
Non Reproducible Results 167 167
Low Test Results 84 84
Erratic Results 28 28
Material Twisted/Bent 8 8
Incorrect Measurement 6 6
Unintended Movement 5 5
Component Missing 5 5
Device Displays Incorrect Message 4 4
Inaccurate Information 4 4
Defective Device 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Circuit Failure 3 3
Loss of or Failure to Bond 3 3
Output 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 2
Failure to Fire 2 2
Failure to Power Up 2 2
Material Integrity Problem 2 2
Device Markings/Labelling Problem 2 2
Incomplete or Missing Packaging 2 2
Activation, Positioning or Separation Problem 2 2
Use of Device Problem 1 1
Battery Problem 1 1
Imprecision 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Difficult to Program or Calibrate 1 1
High Readings 1 1
Product Quality Problem 1 1
Low Readings 1 1
Defective Component 1 1
Failure to Sense 1 1
Insufficient Information 1 1
Nonstandard Device 1 1
Image Display Error/Artifact 1 1
Display Difficult to Read 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 414 414
No Consequences Or Impact To Patient 267 267
Hyperglycemia 15 15
Hypoglycemia 10 10
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 7 7
Shaking/Tremors 3 3
Sweating 2 2
Dizziness 2 2
Diabetic Ketoacidosis 2 2
Coma 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fatigue 1 1
Skin Irritation 1 1
Confusion/ Disorientation 1 1
Weakness 1 1
Aphonia 1 1
Loss of consciousness 1 1
Low Blood Pressure/ Hypotension 1 1

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