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TPLC
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Device
glucose dehydrogenase, glucose
Regulation Description
Glucose test system.
Product Code
LFR
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
172
172
2025
374
374
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
332
332
Erratic Results
247
247
Incorrect, Inadequate or Imprecise Result or Readings
208
208
Non Reproducible Results
121
121
Low Test Results
108
108
Material Twisted/Bent
7
7
Incorrect Measurement
6
6
Device Sensing Problem
5
5
Unintended Movement
5
5
Component Missing
5
5
Inaccurate Information
4
4
Labelling, Instructions for Use or Training Problem
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Loss of or Failure to Bond
3
3
Device Displays Incorrect Message
3
3
No Apparent Adverse Event
3
3
Shipping Damage or Problem
3
3
Contamination /Decontamination Problem
3
3
Defective Device
3
3
Insufficient Information
3
3
Output Problem
3
3
Circuit Failure
3
3
Failure to Power Up
2
2
Use of Device Problem
2
2
Material Integrity Problem
2
2
Failure to Fire
2
2
Display Difficult to Read
2
2
Illegible Information
2
2
Display or Visual Feedback Problem
2
2
Incomplete or Missing Packaging
2
2
Activation, Positioning or Separation Problem
2
2
High Readings
1
1
Defective Component
1
1
Imprecision
1
1
Failure to Sense
1
1
Application Program Problem: Dose Calculation Error
1
1
Device Difficult to Program or Calibrate
1
1
Calibration Problem
1
1
Device Markings/Labelling Problem
1
1
Image Display Error/Artifact
1
1
Communication or Transmission Problem
1
1
Product Quality Problem
1
1
Low Readings
1
1
Appropriate Term/Code Not Available
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
770
770
No Consequences Or Impact To Patient
167
167
Hyperglycemia
41
41
Hypoglycemia
37
37
Insufficient Information
9
9
Loss of consciousness
9
9
Shaking/Tremors
6
6
Diabetic Ketoacidosis
5
5
Dizziness
3
3
Vomiting
3
3
Coma
3
3
Fatigue
2
2
No Known Impact Or Consequence To Patient
2
2
Abdominal Pain
1
1
Syncope/Fainting
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Skin Irritation
1
1
Diaphoresis
1
1
Confusion/ Disorientation
1
1
Numbness
1
1
Tachycardia
1
1
Aphonia
1
1
Headache
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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