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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
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
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 116 116
2020 68 68
2021 48 48
2022 276 276
2023 1159 1159
2024 149 149

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 682 682
Incorrect, Inadequate or Imprecise Result or Readings 360 360
Wireless Communication Problem 360 360
Electrical /Electronic Property Problem 240 240
High Test Results 38 38
Appropriate Term/Code Not Available 38 38
Non Reproducible Results 34 34
Low Test Results 31 31
Communication or Transmission Problem 24 24
Low Readings 10 10
No Apparent Adverse Event 8 8
Battery Problem 7 7
Patient Data Problem 7 7
Material Integrity Problem 7 7
Failure to Sense 7 7
Insufficient Information 6 6
Failure to Power Up 4 4
Device Alarm System 4 4
Problem with Software Installation 4 4
Material Twisted/Bent 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Overheating of Device 3 3
Peeled/Delaminated 3 3
Unauthorized Access to Computer System 3 3
Inaccurate Information 3 3
Physical Resistance/Sticking 3 3
Image Display Error/Artifact 2 2
Failure to Obtain Sample 2 2
Device Displays Incorrect Message 1 1
Therapeutic or Diagnostic Output Failure 1 1
Output Problem 1 1
Expiration Date Error 1 1
Device Markings/Labelling Problem 1 1
Environmental Compatibility Problem 1 1
Failure of Device to Self-Test 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Moisture Damage 1 1
Component Incompatible 1 1
Display Difficult to Read 1 1
Display or Visual Feedback Problem 1 1
Unable to Obtain Readings 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Obstruction of Flow 1 1
Erratic Results 1 1
Explosion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1546 1546
No Known Impact Or Consequence To Patient 82 82
No Consequences Or Impact To Patient 61 61
Insufficient Information 36 36
Hypoglycemia 32 32
Hyperglycemia 25 25
No Patient Involvement 16 16
Shaking/Tremors 7 7
Dizziness 4 4
Discomfort 3 3
Nausea 3 3
Fatigue 3 3
Dysphasia 2 2
Weakness 2 2
Loss of consciousness 2 2
Test Result 2 2
No Information 1 1
Irritability 1 1
Sweating 1 1
Anxiety 1 1
Distress 1 1
Confusion/ Disorientation 1 1
Lethargy 1 1
Chemical Exposure 1 1
Polydipsia 1 1
Burning Sensation 1 1
Complaint, Ill-Defined 1 1
Hypoesthesia 1 1
Diabetic Ketoacidosis 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Syncope 1 1
Endophthalmitis 1 1
Respiratory Distress Syndrome of Newborns 1 1
Therapeutic Effects, Unexpected 1 1
Visual Impairment 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 Medline Industries Inc II Nov-22-2019
4 Ortho-Clinical Diagnostics II Aug-06-2019
5 Polymer Technology Systems, Inc. II May-23-2019
6 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. III Sep-14-2022
7 Randox Laboratories Ltd. II Oct-31-2023
8 Siemens Healthcare Diagnostics Inc II Sep-15-2020
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