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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 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 203 203
High Test Results 188 188
Non Reproducible Results 148 148
Low Test Results 74 74
Material Twisted/Bent 8 8
Unintended Movement 5 5
Incorrect Measurement 5 5
Component Missing 5 5
Manufacturing, Packaging or Shipping Problem 4 4
Defective Device 4 4
Device Displays Incorrect Message 4 4
Inaccurate Information 4 4
Output Problem 3 3
Contamination /Decontamination Problem 3 3
Shipping Damage or Problem 3 3
Loss of or Failure to Bond 3 3
Circuit Failure 2 2
Failure to Power Up 2 2
Incomplete or Missing Packaging 2 2
Activation, Positioning or Separation Problem 2 2
Device Markings/Labelling Problem 2 2
Failure to Fire 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Illegible Information 1 1
Battery Problem 1 1
High Readings 1 1
Use of Device Problem 1 1
Defective Component 1 1
Nonstandard Device 1 1
No Device Output 1 1
Failure to Sense 1 1
Premature Activation 1 1
Device Difficult to Program or Calibrate 1 1
Product Quality Problem 1 1
Display Difficult to Read 1 1
Display or Visual Feedback Problem 1 1
Image Display Error/Artifact 1 1
Imprecision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 321 321
No Consequences Or Impact To Patient 267 267
Hyperglycemia 15 15
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 7 7
Hypoglycemia 7 7
Diabetic Ketoacidosis 2 2
Coma 2 2
Sweating 2 2
Dizziness 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Shaking/Tremors 1 1
Aphonia 1 1
Loss of consciousness 1 1
Low Blood Pressure/ Hypotension 1 1
Skin Irritation 1 1
Weakness 1 1

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