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TPLC
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show TPLC since
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Device
glucose dehydrogenase, glucose
Product Code
LFR
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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