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TPLC
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show TPLC since
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Device
glucose oxidase, glucose
Regulation Description
Glucose test system.
Product Code
CGA
Regulation Number
862.1345
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT POINT OF CARE INC.
SUBSTANTIALLY EQUIVALENT
3
ABBOTT POINT OF CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
ALERE SAN DIEGO, INC.
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY CO
SUBSTANTIALLY EQUIVALENT
1
MEDICA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
YSI INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
68
68
2021
48
48
2022
276
276
2023
1159
1159
2024
299
299
2025
31
31
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
688
688
Wireless Communication Problem
367
367
Incorrect, Inadequate or Imprecise Result or Readings
360
360
Electrical /Electronic Property Problem
186
186
High Test Results
86
86
Erratic Results
57
57
Low Test Results
50
50
Appropriate Term/Code Not Available
37
37
Non Reproducible Results
31
31
Communication or Transmission Problem
24
24
No Apparent Adverse Event
8
8
Material Integrity Problem
8
8
Low Readings
8
8
Failure to Sense
7
7
Battery Problem
7
7
Patient Data Problem
7
7
Insufficient Information
6
6
Failure to Power Up
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Problem with Software Installation
4
4
Unauthorized Access to Computer System
3
3
Inaccurate Information
3
3
Device Alarm System
3
3
Material Twisted/Bent
3
3
Display or Visual Feedback Problem
2
2
Physical Resistance/Sticking
2
2
Unable to Obtain Readings
1
1
Environmental Compatibility Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Failure of Device to Self-Test
1
1
Device Markings/Labelling Problem
1
1
Expiration Date Error
1
1
Obstruction of Flow
1
1
Improper or Incorrect Procedure or Method
1
1
Moisture Damage
1
1
Component Incompatible
1
1
Therapeutic or Diagnostic Output Failure
1
1
Failure to Obtain Sample
1
1
Overheating of Device
1
1
Display Difficult to Read
1
1
Incorrect Measurement
1
1
Defective Component
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1705
1705
Hypoglycemia
45
45
Insufficient Information
37
37
Hyperglycemia
27
27
No Consequences Or Impact To Patient
26
26
No Known Impact Or Consequence To Patient
22
22
No Patient Involvement
5
5
Dizziness
5
5
Loss of consciousness
4
4
Shaking/Tremors
4
4
Fatigue
3
3
Discomfort
3
3
Test Result
2
2
Dysphasia
2
2
Syncope/Fainting
1
1
Therapeutic Effects, Unexpected
1
1
Convulsion/Seizure
1
1
Headache
1
1
Irritability
1
1
Diabetic Ketoacidosis
1
1
Nausea
1
1
Distress
1
1
No Information
1
1
Burning Sensation
1
1
Stroke/CVA
1
1
Complaint, Ill-Defined
1
1
Hemorrhage/Bleeding
1
1
Respiratory Distress Syndrome of Newborns
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego, Inc.
II
Apr-30-2024
2
Alere San Diego, Inc.
II
Aug-06-2022
3
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
III
Sep-14-2022
4
Randox Laboratories Ltd.
II
Oct-31-2023
5
Siemens Healthcare Diagnostics Inc
II
Sep-15-2020
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