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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device glucose oxidase, glucose
Regulation Description Glucose test system.
Product CodeCGA
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
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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