• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 3
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYMER TECHNOLOGY SYSTEMS, INC. D/B/A PTS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT - KIT 1

MDR Year MDR Reports MDR Events
2018 69 69
2019 116 116
2020 68 68
2021 48 48
2022 276 276
2023 1034 1034

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 661 661
Wireless Communication Problem 339 339
Electrical /Electronic Property Problem 220 220
Incorrect, Inadequate or Imprecise Result or Readings 212 212
Appropriate Term/Code Not Available 35 35
Low Test Results 32 32
High Test Results 24 24
Communication or Transmission Problem 23 23
Non Reproducible Results 20 20
Incorrect Or Inadequate Test Results 12 12
Low Readings 10 10
No Apparent Adverse Event 8 8
Insufficient Information 7 7
Battery Problem 7 7
Patient Data Problem 7 7
Failure to Sense 7 7
Peeled/Delaminated 4 4
Failure to Power Up 4 4
Device Alarm System 4 4
Overheating of Device 3 3
Unable to Obtain Readings 3 3
Defective Component 3 3
Inaccurate Information 3 3
Unauthorized Access to Computer System 3 3
Material Twisted/Bent 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Output Problem 3 3
Problem with Software Installation 2 2
Material Integrity Problem 2 2
Failure to Obtain Sample 2 2
Image Display Error/Artifact 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 1 1
Off-Label Use 1 1
Loss of Power 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Moisture Damage 1 1
Component Incompatible 1 1
Display or Visual Feedback Problem 1 1
Device Displays Incorrect Message 1 1
Expiration Date Error 1 1
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Environmental Compatibility Problem 1 1
Failure of Device to Self-Test 1 1
Obstruction of Flow 1 1
High Readings 1 1
Therapeutic or Diagnostic Output Failure 1 1
Erratic Results 1 1
Device Handling Problem 1 1
Explosion 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1295 1295
No Known Impact Or Consequence To Patient 107 107
No Consequences Or Impact To Patient 75 75
Insufficient Information 36 36
No Patient Involvement 24 24
Hyperglycemia 23 23
Hypoglycemia 23 23
Shaking/Tremors 8 8
Dizziness 6 6
No Information 5 5
Sweating 4 4
Ambulation Difficulties 3 3
Confusion/ Disorientation 3 3
Discomfort 3 3
Weakness 3 3
Nausea 3 3
Fatigue 3 3
Headache 2 2
Loss of consciousness 2 2
Test Result 2 2
Lethargy 1 1
Chemical Exposure 1 1
Polydipsia 1 1
Complaint, Ill-Defined 1 1
Hypoesthesia 1 1
Numbness 1 1
Urinary Frequency 1 1
Anxiety 1 1
Distress 1 1
Hemorrhage/Bleeding 1 1
Fever 1 1
Abnormal Blood Gases 1 1
Syncope 1 1
Endophthalmitis 1 1
Fainting 1 1
Respiratory Distress Syndrome of Newborns 1 1
Seizures 1 1
Therapeutic Effects, Unexpected 1 1
Visual Impairment 1 1
Burning Sensation 1 1
Chills 1 1
Dysphasia 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alere San Diego, Inc. II Aug-06-2022
2 Medline Industries Inc II Nov-22-2019
3 Ortho-Clinical Diagnostics II Aug-06-2019
4 Polymer Technology Systems, Inc. II May-23-2019
5 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. III Sep-14-2022
6 Siemens Healthcare Diagnostics Inc II Sep-15-2020
-
-