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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
2018 108 108
2019 108 108
2020 132 132
2021 164 164
2022 101 101
2023 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 181 181
Incorrect, Inadequate or Imprecise Result or Readings 171 171
Non Reproducible Results 144 144
Low Test Results 86 86
Incorrect Or Inadequate Test Results 11 11
Material Twisted/Bent 8 8
Device Displays Incorrect Message 7 7
Unintended Movement 5 5
Inaccurate Information 4 4
Incorrect Measurement 4 4
Loss of or Failure to Bond 3 3
Defective Device 3 3
Manufacturing, Packaging or Shipping Problem 2 2
Failure to Fire 2 2
Activation, Positioning or Separation Problem 2 2
Device Markings/Labelling Problem 2 2
Failure to Power Up 2 2
Defective Component 2 2
High Readings 2 2
Nonstandard Device 1 1
Loss of Power 1 1
Failure to Sense 1 1
Use of Device Problem 1 1
Premature Activation 1 1
Device Difficult to Program or Calibrate 1 1
Product Quality Problem 1 1
Unable to Obtain Readings 1 1
Break 1 1
Circuit Failure 1 1
False Reading From Device Non-Compliance 1 1
Image Display Error/Artifact 1 1
Device Contamination with Chemical or Other Material 1 1
Battery Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Illegible Information 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 332 332
No Clinical Signs, Symptoms or Conditions 214 214
No Known Impact Or Consequence To Patient 42 42
Hyperglycemia 15 15
Insufficient Information 7 7
No Information 5 5
Hypoglycemia 5 5
Coma 2 2
Sweating 2 2
Dizziness 2 2
Shaking/Tremors 1 1
Device Embedded In Tissue or Plaque 1 1
Aphonia 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Loss of consciousness 1 1
Diabetic Ketoacidosis 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
2 Roche Diabetes Care, Inc. II May-09-2018
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