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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 1
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ORTHO CLINICAL DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
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
2017 92 92
2018 69 69
2019 116 116
2020 68 68
2021 49 49
2022 675 675

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 510 510
Electrical /Electronic Property Problem 178 178
Communication or Transmission Problem 125 125
Incorrect, Inadequate or Imprecise Resultor Readings 61 61
Low Test Results 36 36
High Test Results 26 26
High Readings 23 23
Appropriate Term/Code Not Available 20 20
Incorrect Or Inadequate Test Results 19 19
No Apparent Adverse Event 12 12
Low Readings 11 11
Failure to Sense 7 7
Patient Data Problem 7 7
Adverse Event Without Identified Device or Use Problem 5 5
Failure to Power Up 5 5
Peeled/Delaminated 4 4
Device Displays Incorrect Message 4 4
Output Problem 4 4
Non Reproducible Results 4 4
Insufficient Information 3 3
Device Operates Differently Than Expected 3 3
Material Twisted/Bent 3 3
Defective Component 3 3
Overheating of Device 3 3
Unable to Obtain Readings 3 3
Loss of Power 2 2
Device Alarm System 2 2
Image Display Error/Artifact 2 2
Image Resolution Poor 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Obtain Sample 2 2
Problem with Software Installation 2 2
Device Markings/Labelling Problem 1 1
Device Operational Issue 1 1
Failure of Device to Self-Test 1 1
Human Factors Issue 1 1
Erratic Results 1 1
Device Handling Problem 1 1
Wireless Communication Problem 1 1
Explosion 1 1
Physical Resistance/Sticking 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Expiration Date Error 1 1
Device Damaged Prior to Use 1 1
Sticking 1 1
Invalid Sensing 1 1
Component Missing 1 1
Difficult to Insert 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Component Incompatible 1 1
Material Discolored 1 1
Display or Visual Feedback Problem 1 1
Material Fragmentation 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 547 547
Insufficient Information 176 176
No Known Impact Or Consequence To Patient 165 165
No Consequences Or Impact To Patient 78 78
No Patient Involvement 32 32
Hypoglycemia 17 17
Hyperglycemia 14 14
No Information 10 10
Shaking/Tremors 8 8
Sweating 5 5
Dizziness 4 4
Weakness 3 3
Ambulation Difficulties 3 3
Confusion/ Disorientation 3 3
Nausea 3 3
Headache 3 3
Test Result 3 3
No Code Available 3 3
Polydipsia 2 2
Fatigue 2 2
Skin Irritation 2 2
Loss of consciousness 2 2
Anxiety 2 2
Discomfort 1 1
Complaint, Ill-Defined 1 1
Hypoesthesia 1 1
Numbness 1 1
Burning Sensation 1 1
Chills 1 1
Dysphasia 1 1
Urinary Frequency 1 1
Lethargy 1 1
Chemical Exposure 1 1
Tachycardia 1 1
Therapeutic Effects, Unexpected 1 1
Visual Impairment 1 1
Renal Failure 1 1
Respiratory Distress Syndrome of Newborns 1 1
Seizures 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Abnormal Blood Gases 1 1
Syncope 1 1
Endophthalmitis 1 1
Fainting 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medline Industries Inc II Nov-22-2019
2 Ortho-Clinical Diagnostics II Aug-06-2019
3 Polymer Technology Systems, Inc. II May-23-2019
4 Siemens Healthcare Diagnostics Inc II Sep-15-2020
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