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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 DIABETES CARE INC.
  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 BIO TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 4
APPLIED BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ARKRAY FACTORY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENSIA DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 3
ASCENSIA DIABETES CARE US INC.
  SUBSTANTIALLY EQUIVALENT 2
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 3
FORACARE INC.
  SUBSTANTIALLY EQUIVALENT 1
HMD BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 9
INFOPIA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTUITY MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
INTUITY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
IXENSOR COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1
LABSTYLE INNOVATION, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LABSTYLE INNOVATIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFESCAN EUROPE GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIVONGO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTECH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
OK BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
OSANG HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SD BIOSENSOR
  SUBSTANTIALLY EQUIVALENT 2
SINOCARE MEDITECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN EMPECS MEDICAL DEVICE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TRIVIDIA HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TYSON BIORESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 3
VIVACHEK LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 76553 76553
2017 37535 37535
2018 16903 16903
2019 14471 14471
2020 10702 10702
2021 6687 6687

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 42068 42068
Device Displays Incorrect Message 38749 38749
Incorrect, Inadequate or Imprecise Resultor Readings 14869 14869
Incorrect Or Inadequate Test Results 13486 13486
Loss of Power 7636 7636
High Test Results 7393 7393
Device Operates Differently Than Expected 5075 5075
Device Alarm System 3439 3439
Low Test Results 2240 2240
Appropriate Term/Code Not Available 2220 2220
No Display/Image 1904 1904
Battery Problem 1869 1869
Low Battery 1833 1833
High Readings 1766 1766
Component Missing 1647 1647
Charging Problem 1250 1250
Adverse Event Without Identified Device or Use Problem 1123 1123
Device Operational Issue 1067 1067
Insufficient Information 1059 1059
Device Damaged Prior to Use 1045 1045
Display Difficult to Read 1040 1040
Missing Test Results 948 948
False Reading From Device Non-Compliance 784 784
Sticking 743 743
Output Problem 570 570
Device Inoperable 560 560
Image Resolution Poor 544 544
Low Readings 468 468
Unable to Obtain Readings 427 427
Device Stops Intermittently 425 425
Image Display Error/Artifact 418 418
No Device Output 382 382
Inappropriate Audible Prompt/Feedback 370 370
Device Handling Problem 369 369
Electrical /Electronic Property Problem 365 365
Display or Visual Feedback Problem 350 350
Crack 340 340
Failure to Charge 335 335
Use of Incorrect Control Settings 327 327
Poor Quality Image 305 305
Failure to Calibrate 292 292
Incorrect Software Programming Calculations 276 276
Defective Component 273 273
Application Program Problem: Dose Calculation Error 258 258
Bent 251 251
Off-Label Use 242 242
Failure to Obtain Sample 209 209
Break 207 207
Material Discolored 200 200
Data Problem 177 177
Material Integrity Problem 171 171
Labelling, Instructions for Use or Training Problem 155 155
Physical Property Issue 155 155
Device Ingredient or Reagent Problem 130 130
Failure to Back-Up 128 128
Packaging Problem 124 124
Improper or Incorrect Procedure or Method 115 115
Premature Discharge of Battery 113 113
Device Markings/Labelling Problem 107 107
Inadequate Instructions for Healthcare Professional 101 101
Device Difficult to Setup or Prepare 101 101
Defective Device 100 100
Therapeutic or Diagnostic Output Failure 96 96
Improper Device Output 89 89
Reset Problem 88 88
Power Problem 86 86
Unsealed Device Packaging 86 86
Incomplete or Missing Packaging 78 78
Failure to Shut Off 74 74
Incorrect Measurement 72 72
Erratic or Intermittent Display 68 68
No Apparent Adverse Event 64 64
Melted 55 55
Inappropriate or Unexpected Reset 54 54
Loss of Data 48 48
Product Quality Problem 48 48
Application Program Problem 47 47
Computer Software Problem 42 42
Computer Operating System Problem 41 41
Nonstandard Device 37 37
Peeled/Delaminated 30 30
Material Opacification 29 29
Cut In Material 29 29
Incorrect Device Or Component Shipped 28 28
Thermal Decomposition of Device 26 26
Device Packaging Compromised 26 26
Operating System Becomes Nonfunctional 25 25
Self-Activation or Keying 25 25
Contamination 24 24
Communication or Transmission Problem 22 22
Smoking 21 21
Use of Device Problem 21 21
Calibration Error 21 21
Application Interface Becomes Non-Functional Or Program Exits Abnormally 20 20
Invalid Sensing 20 20
Device Expiration Issue 19 19
Connection Problem 17 17
Manufacturing, Packaging or Shipping Problem 17 17
Data Back-Up Problem 17 17
Date/Time-Related Software Problem 16 16

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 63404 63404
No Clinical Signs, Symptoms or Conditions 5765 5765
Hyperglycemia 3311 3312
Hypoglycemia 2993 2994
Shaking/Tremors 2464 2465
Dizziness 2155 2156
Sweating 2082 2082
Loss of consciousness 898 898
Fatigue 794 794
Headache 791 791
Weakness 781 781
Blurred Vision 773 773
Confusion/ Disorientation 743 744
Polydipsia 525 526
Nausea 463 463
No Code Available 456 456
Urinary Frequency 449 449
Fainting 408 408
Lethargy 360 360
No Information 288 288
Dysphasia 240 240
Vomiting 218 218
Syncope 218 218
Anxiety 205 205
Insufficient Information 201 201
Seizures 168 168
Diaphoresis 166 166
Diabetic Ketoacidosis 160 160
Malaise 131 131
Tachycardia 121 121
Alteration In Body Temperature 106 107
No Patient Involvement 102 102
Coma 91 91
Fall 85 85
Dyspnea 82 82
Visual Impairment 77 77
Palpitations 76 76
Dehydration 73 73
Ambulation Difficulties 72 72
Numbness 69 69
Complaint, Ill-Defined 69 69
Vertigo 68 68
Cognitive Changes 65 65
Chills 63 63
Pain 58 58
Chest Pain 55 55
Abdominal Pain 53 53
Irritability 48 48
Syncope/Fainting 44 44
Convulsion/Seizure 41 41
Tingling 39 39
High Blood Pressure/ Hypertension 37 37
Patient Problem/Medical Problem 35 36
Muscle Weakness 33 33
Hot Flashes/Flushes 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 28 28
Diarrhea 27 27
Collapse 26 26
Paresis 25 25
Memory Loss/Impairment 24 24
Fever 23 23
Pallor 23 23
Extreme Exhaustion 21 21
Presyncope 21 21
Emotional Changes 19 19
Swelling 18 18
Loss of Vision 18 18
Visual Disturbances 17 17
Cramp(s) 16 16
Shock, Insulin 16 16
Overdose 14 14
Death 14 14
Alteration in Body Temperature 14 14
Sleep Dysfunction 14 14
Not Applicable 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
Head Injury 8 8
Bone Fracture(s) 8 8
Test Result 8 8
Weight Changes 8 8
Chest Tightness/Pressure 8 8
Injury 8 8
Blood Loss 7 7
Angina 7 7
Distress 7 7
Respiratory Distress 7 7
Tinnitus 7 7
Paralysis 7 7
Pneumonia 7 7
Low Blood Pressure/ Hypotension 7 7
Hypothermia 7 7
Urinary Tract Infection 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 Cardinal Health Inc. II Jun-23-2021
4 LABSTYLE INNOVATIONS II Oct-31-2019
5 Livongo Health II Apr-29-2016
6 Polymer Technology Systems, Inc. II Jan-21-2020
7 Polymer Technology Systems, Inc. II Dec-26-2019
8 Polymer Technology Systems, Inc. II Apr-28-2018
9 Roche Diabetes Care, Inc. II Aug-26-2021
10 Roche Diabetes Care, Inc. II Feb-05-2020
11 Roche Diabetes Care, Inc. II Dec-30-2019
12 Roche Diabetes Care, Inc. II Sep-30-2019
13 Trividia Health II Sep-23-2016
14 Trividia Health, Inc. II Jun-01-2020
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