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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, blood glucose, over the counter
Regulation Description Glucose test system.
Product CodeNBW
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
ACON LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
AGAMATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALL MEDICUS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO.,LTD
  SUBSTANTIALLY EQUIVALENT 5
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ARKRAY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENSIA DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 2
ASCENSIA DIABETES CARE HOLDINGS AG
  SUBSTANTIALLY EQUIVALENT 2
BIOLAND
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
BIOTEST MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ENTRA HEALTH SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
EPS BIO TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 2
INTUITY MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 8
NOVA
  SUBSTANTIALLY EQUIVALENT 2
NOVA BIOMEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
OK BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
OSANG HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SD BIOSENSOR, INC.
  SUBSTANTIALLY EQUIVALENT 2
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIVIDIA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYSON BIORESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2016 76532 76532
2017 37530 37530
2018 16902 16902
2019 14471 14471
2020 10702 10702
2021 1873 1873

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 39269 39269
Device Displays Incorrect Message 38693 38693
Incorrect, Inadequate or Imprecise Resultor Readings 13910 13910
Incorrect Or Inadequate Test Results 13486 13486
Loss of Power 7617 7617
High Test Results 7186 7186
Device Operates Differently Than Expected 5074 5074
Device Alarm System 3436 3436
Gauges/Meters 2663 2663
Appropriate Term/Code Not Available 2201 2201
Low Test Results 2174 2174
No Display/Image 1903 1903
Battery Problem 1855 1855
Low Battery 1833 1833
High Readings 1691 1691
Component Missing 1647 1647
Charging Problem 1250 1250
Adverse Event Without Identified Device or Use Problem 1094 1094
Device Operational Issue 1067 1067
Device Damaged Prior to Use 1045 1045
Insufficient Information 1043 1043
Test Strip 1008 1008
Missing Test Results 860 860
Display Difficult to Read 832 832
False Reading From Device Non-Compliance 783 783
Sticking 742 742
Housing 605 605
Output Problem 566 566
Device Inoperable 560 560
Image Resolution Poor 544 544
Battery 515 515
Display 495 495
Low Readings 426 426
Device Stops Intermittently 425 425
Cover 413 413
Switch, Push Button 397 397
Unable to Obtain Readings 379 379
Inappropriate Audible Prompt/Feedback 370 370
Electrical /Electronic Property Problem 364 364
No Device Output 363 363
Device Handling Problem 349 349
Image Display Error/Artifact 346 346
Display or Visual Feedback Problem 342 342
Crack 340 340
Failure to Charge 335 335
Use of Incorrect Control Settings 326 326
Poor Quality Image 305 305
Failure to Calibrate 288 288
Incorrect Software Programming Calculations 276 276
Defective Component 270 270
Bent 251 251
Off-Label Use 242 242
Application Program Problem: Dose Calculation Error 239 239
Failure to Obtain Sample 209 209
Break 204 204
Material Discolored 199 199
Data Problem 176 176
Material Integrity Problem 171 171
Physical Property Issue 155 155
Labelling, Instructions for Use or Training Problem 154 154
Device Ingredient or Reagent Problem 130 130
Failure to Back-Up 128 128
Packaging Problem 123 123
Improper or Incorrect Procedure or Method 110 110
Premature Discharge of Battery 108 108
Device Markings/Labelling Problem 107 107
Inadequate Instructions for Healthcare Professional 101 101
Device Difficult to Setup or Prepare 101 101
Defective Device 96 96
Therapeutic or Diagnostic Output Failure 93 93
Improper Device Output 89 89
Reset Problem 88 88
Unsealed Device Packaging 86 86
Power Problem 80 80
Label 80 80
Incomplete or Missing Packaging 78 78
Failure to Shut Off 74 74
Port 73 73
Erratic or Intermittent Display 68 68
Incorrect Measurement 68 68
Indicator 61 61
Screen 58 58
Device Subassembly 56 56
Inappropriate or Unexpected Reset 54 54
Cable, Electrical 49 49
Memory/Storage 48 48
Melted 48 48
Loss of Data 48 48
Application Program Problem 47 47
Unit 45 45
Product Quality Problem 42 42
Computer Software Problem 41 41
Computer Operating System Problem 41 41
Material Opacification 29 29
Cut In Material 29 29
Peeled/Delaminated 29 29
Incorrect Device Or Component Shipped 28 28
Nonstandard Device 28 28
Adapter (Adaptor) 26 26
Device Packaging Compromised 26 26

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 79760 79760
No Consequences Or Impact To Patient 63373 63373
Hyperglycemia 3095 3096
Hypoglycemia 2773 2774
Shaking/Tremors 2373 2374
Sweating 2082 2082
Dizziness 2010 2011
No Clinical Signs, Symptoms or Conditions 1862 1862
Loss of consciousness 811 811
Weakness 781 781
Blurred Vision 742 742
Fatigue 740 740
Headache 733 733
Confusion/ Disorientation 717 718
Polydipsia 505 506
No Code Available 456 456
Urinary Frequency 438 438
Nausea 437 437
Fainting 408 408
Lethargy 339 339
No Information 288 288
Dysphasia 230 230
Syncope 218 218
Vomiting 202 202
Anxiety 194 194
Seizures 169 169
Diabetic Ketoacidosis 150 150
Malaise 123 123
Tachycardia 117 117
Alteration In Body Temperature 106 107
No Patient Involvement 102 102
Diaphoresis 84 84
Coma 79 79
Palpitations 76 76
Fall 76 76
Dyspnea 73 73
Visual Impairment 73 73
Complaint, Ill-Defined 69 69
Dehydration 69 69
Numbness 69 69
Ambulation Difficulties 69 69
Insufficient Information 68 68
Chills 59 59
Cognitive Changes 58 58
Pain 57 57
Vertigo 56 56
Chest Pain 51 51
Abdominal Pain 48 48
Irritability 45 45
Tingling 39 39
Patient Problem/Medical Problem 35 36
High Blood Pressure/ Hypertension 34 34
Hot Flashes/Flushes 31 31
Collapse 26 26
Fever 23 23
Syncope/Fainting 23 23
Diarrhea 22 22
Paresis 21 21
Pallor 21 21
Memory Loss/Impairment 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Extreme Exhaustion 19 19
Loss of Vision 18 18
Swelling 18 18
Emotional Changes 17 17
Muscle Weakness 16 16
Cramp(s) 16 16
Shock, Insulin 16 16
Presyncope 15 15
Visual Disturbances 15 15
Convulsion/Seizure 15 15
Overdose 14 14
Death 14 14
Not Applicable 13 13
Sleep Dysfunction 13 13
Missing Value Reason 12 12
Unspecified Infection 12 12
Itching Sensation 11 11
Twitching 10 10
Abdominal Cramps 9 9
Neuropathy 8 8
Burning Sensation 8 8
Incontinence 8 8
Test Result 8 8
Chest Tightness/Pressure 8 8
Injury 8 8
Alteration in Body Temperature 8 8
Distress 7 7
Blood Loss 7 7
Weight Changes 7 7
Bone Fracture(s) 7 7
Respiratory Distress 7 7
Paralysis 7 7
Pneumonia 7 7
Tinnitus 7 7
Hypothermia 7 7
Low Blood Pressure/ Hypotension 6 6
Urinary Tract Infection 6 6
Head Injury 6 6
Eye Injury 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Feb-28-2020
2 Cambridge Sensors Limited II Aug-22-2019
3 LABSTYLE INNOVATIONS II Oct-31-2019
4 Livongo Health II Apr-29-2016
5 Polymer Technology Systems, Inc. II Jan-21-2020
6 Polymer Technology Systems, Inc. II Dec-26-2019
7 Polymer Technology Systems, Inc. II Apr-28-2018
8 Roche Diabetes Care, Inc. II Feb-05-2020
9 Roche Diabetes Care, Inc. II Dec-30-2019
10 Roche Diabetes Care, Inc. II Sep-30-2019
11 Trividia Health II Sep-23-2016
12 Trividia Health, Inc. II Jun-01-2020
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