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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
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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