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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
AGAMATRIX
  SUBSTANTIALLY EQUIVALENT 1
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 7
ASCENSIA DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 3
ASCENSIA DIABETES CARE US INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EPS BIO TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HMD BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 4
LIFESCAN EUROPE GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIVONGO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTECH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIO LABS INC.
  SUBSTANTIALLY EQUIVALENT 1
OK BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSANG HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
POLYMER TECHNOLOGY SYSTEMS, INC. D/B/A PTS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
SEJOY BIOMEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SINOCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VIVACHEK BIOTECH (HANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
  1.  K233058  VivaChek Link Plus Blood Glucose Monitoring System
VIVACHEK BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K233058  VivaChek Link Plus Blood Glucose Monitoring System

MDR Year MDR Reports MDR Events
2020 10702 10702
2021 9196 9196
2022 8103 8103
2023 7258 7258
2024 6220 6220
2025 1656 1656

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 27449 27449
Incorrect, Inadequate or Imprecise Result or Readings 7048 7048
High Test Results 1919 1919
Display Difficult to Read 1484 1484
High Readings 866 866
Missing Test Results 631 631
Low Test Results 603 603
Image Display Error/Artifact 596 596
Device Displays Incorrect Message 433 433
Low Readings 340 340
Unable to Obtain Readings 274 274
Display or Visual Feedback Problem 223 223
Adverse Event Without Identified Device or Use Problem 198 198
Device Handling Problem 185 185
No Device Output 152 152
Erratic Results 149 149
Nonstandard Device 142 142
Insufficient Information 103 103
Application Program Problem: Dose Calculation Error 97 97
No Apparent Adverse Event 95 95
Power Problem 95 95
Product Quality Problem 70 70
Loss of Power 65 65
Battery Problem 61 61
Appropriate Term/Code Not Available 59 59
Device Alarm System 47 47
Incorrect Measurement 42 42
Output Problem 42 42
Unsealed Device Packaging 37 37
Premature Discharge of Battery 26 26
Melted 26 26
Failure to Calibrate 23 23
No Display/Image 19 19
Incomplete or Missing Packaging 19 19
Overheating of Device 17 17
Circuit Failure 17 17
Smoking 15 15
Material Twisted/Bent 14 14
Therapeutic or Diagnostic Output Failure 14 14
Missing Information 14 14
Defective Device 13 13
Improper or Incorrect Procedure or Method 12 12
Non Reproducible Results 11 11
Physical Resistance/Sticking 11 11
Temperature Problem 11 11
Fire 10 10
Use of Device Problem 10 10
Calibration Problem 10 10
Material Integrity Problem 9 9
Device Markings/Labelling Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28156 28156
No Known Impact Or Consequence To Patient 6495 6495
No Consequences Or Impact To Patient 2550 2550
Hypoglycemia 1540 1540
Hyperglycemia 1382 1382
Dizziness 934 934
Shaking/Tremors 721 721
Loss of consciousness 609 609
Insufficient Information 556 556
Fatigue 441 441
Diaphoresis 426 426
Headache 331 331
Blurred Vision 249 249
Confusion/ Disorientation 229 229
Polydipsia 182 182
Nausea 174 174
Lethargy 170 170
Sweating 167 167
Convulsion/Seizure 145 145
Dysphasia 143 143
Syncope/Fainting 137 137
Urinary Frequency 136 136
Muscle Weakness 122 122
Vomiting 121 121
Presyncope 116 116
Diabetic Ketoacidosis 91 91
Weakness 76 76
Anxiety 74 74
Malaise 68 68
Coma 58 58
Dry Mouth 54 54
Fainting 51 51
Dyspnea 48 48
Dehydration 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Fall 41 41
Vertigo 38 38
No Code Available 34 34
Alteration in Body Temperature 33 33
Pain 31 31
Paresis 30 30
Seizures 30 30
Chills 27 27
Ambulation Difficulties 27 27
Tachycardia 26 26
Visual Impairment 24 24
Syncope 24 24
Cognitive Changes 24 24
No Patient Involvement 23 23
No Information 23 23

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Feb-28-2020
2 Ascensia Diabetes Care US, Inc. II Jul-20-2023
3 Cardinal Health Inc. II Jun-23-2021
4 Polymer Technology Systems, Inc. II Jan-21-2020
5 Roche Diabetes Care, Inc. II Jun-21-2024
6 Roche Diabetes Care, Inc. II Aug-26-2021
7 Roche Diabetes Care, Inc. II Feb-05-2020
8 Telcare, LLC II Mar-05-2025
9 Touch US Llc II Jul-26-2022
10 Trividia Health, Inc. II Jun-01-2020
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