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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 1
ABBOTT POINT OF CARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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 1343 1343

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 974 974
Electrical /Electronic Property Problem 194 194
Communication or Transmission Problem 185 185
Wireless Communication Problem 106 106
Incorrect, Inadequate or Imprecise Result or Readings 74 74
Low Test Results 37 37
Appropriate Term/Code Not Available 35 35
High Test Results 28 28
High Readings 23 23
Incorrect Or Inadequate Test Results 19 19
No Apparent Adverse Event 15 15
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
Problem with Software Installation 4 4
Insufficient Information 4 4
Battery Problem 4 4
Non Reproducible Results 4 4
Material Twisted/Bent 3 3
Device Operates Differently Than Expected 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
Failure of Device to Self-Test 2 2
Human Factors Issue 1 1
Material Integrity Problem 1 1
Device Operational Issue 1 1
Environmental Compatibility Problem 1 1
Device Markings/Labelling Problem 1 1
Device Handling Problem 1 1
Explosion 1 1
Physical Resistance/Sticking 1 1
Erratic Results 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
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Incorrect Measurement 1 1
Break 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 1198 1198
Insufficient Information 183 183
No Known Impact Or Consequence To Patient 165 165
No Consequences Or Impact To Patient 78 78
No Patient Involvement 32 32
Hyperglycemia 22 22
Hypoglycemia 17 17
No Information 10 10
Shaking/Tremors 8 8
Sweating 5 5
Dizziness 4 4
Weakness 3 3
Discomfort 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
Anxiety 2 2
Loss of consciousness 2 2
Urinary Frequency 1 1
Lethargy 1 1
Chemical Exposure 1 1
Complaint, Ill-Defined 1 1
Hypoesthesia 1 1
Numbness 1 1
Burning Sensation 1 1
Chills 1 1
Dysphasia 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 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
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