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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 296 296
2025 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 689 689
Wireless Communication Problem 371 371
Incorrect, Inadequate or Imprecise Result or Readings 361 361
Electrical /Electronic Property Problem 191 191
High Test Results 80 80
Low Test Results 52 52
Erratic Results 49 49
Appropriate Term/Code Not Available 37 37
Non Reproducible Results 35 35
Communication or Transmission Problem 24 24
No Apparent Adverse Event 9 9
Low Readings 8 8
Material Integrity Problem 8 8
Battery Problem 7 7
Patient Data Problem 7 7
Failure to Sense 7 7
Insufficient Information 6 6
Problem with Software Installation 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Failure to Power Up 4 4
Unauthorized Access to Computer System 3 3
Material Twisted/Bent 3 3
Inaccurate Information 3 3
Device Alarm System 3 3
Physical Resistance/Sticking 2 2
Display or Visual Feedback Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Output Problem 1 1
Data Problem 1 1
Display Difficult to Read 1 1
Labelling, Instructions for Use or Training Problem 1 1
Incorrect Measurement 1 1
Moisture Damage 1 1
Overheating of Device 1 1
Unable to Obtain Readings 1 1
Component Incompatible 1 1
Obstruction of Flow 1 1
High Readings 1 1
Defective Component 1 1
Expiration Date Error 1 1
Failure to Obtain Sample 1 1
Improper or Incorrect Procedure or Method 1 1
Device Markings/Labelling Problem 1 1
Environmental Compatibility Problem 1 1
Failure of Device to Self-Test 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1705 1705
Hypoglycemia 47 47
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
Discomfort 3 3
Fatigue 3 3
Diabetic Ketoacidosis 2 2
Test Result 2 2
Dysphasia 2 2
Distress 1 1
Complaint, Ill-Defined 1 1
Irritability 1 1
No Information 1 1
Convulsion/Seizure 1 1
Nausea 1 1
Respiratory Distress Syndrome of Newborns 1 1
Therapeutic Effects, Unexpected 1 1
Burning Sensation 1 1
Stroke/CVA 1 1
Headache 1 1
Hemorrhage/Bleeding 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 Mckesson Medical-Surgical Inc. Corporate Office II May-27-2025
4 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. III Sep-14-2022
5 Randox Laboratories Ltd. II Oct-31-2023
6 Siemens Healthcare Diagnostics Inc II Sep-15-2020
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