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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
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AGAMATRIX
  SUBSTANTIALLY EQUIVALENT 1
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 7
ASCENSIA DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 3
ASCENSIA DIABETES CARE U.S., INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOLAND TECHNOLOGY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 2
MIO LABS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K223722  MIO Blood Glucose Monitoring System
OK BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OSANG HEALTHCARE CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 2

MDR Year MDR Reports MDR Events
2021 9198 9227
2022 8103 8139
2023 7256 7261
2024 6220 6222
2025 4810 4810
2026 1972 1972

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 25131 25131
Incorrect, Inadequate or Imprecise Result or Readings 5276 5292
High Test Results 1641 1641
Display Difficult to Read 1117 1117
High Readings 683 694
Image Display Error/Artifact 596 596
Low Test Results 537 537
Missing Test Results 464 464
Low Readings 320 329
Display or Visual Feedback Problem 271 271
Unable to Obtain Readings 252 253
Device Displays Incorrect Message 242 252
Erratic Results 193 193
Nonstandard Device 189 189
Adverse Event Without Identified Device or Use Problem 150 151
Device Handling Problem 137 137
No Device Output 114 114
Product Quality Problem 99 105
Power Problem 94 94
No Apparent Adverse Event 92 92
Insufficient Information 91 91
Application Program Problem: Dose Calculation Error 57 57
Loss of Power 48 48
Appropriate Term/Code Not Available 44 44
Device Alarm System 40 40
Battery Problem 39 39
Unsealed Device Packaging 34 34
Output Problem 32 34
Incorrect Measurement 31 31
Defective Device 27 28
Failure to Calibrate 23 23
Premature Discharge of Battery 22 22
Melted 21 21
Overheating of Device 20 20
Therapeutic or Diagnostic Output Failure 17 37
Data Problem 15 15
Circuit Failure 13 14
Physical Resistance/Sticking 12 12
No Display/Image 12 12
Incomplete or Missing Packaging 11 11
Improper or Incorrect Procedure or Method 11 12
Missing Information 11 11
Temperature Problem 11 11
Component Missing 10 10
Calibration Problem 10 10
Use of Incorrect Control/Treatment Settings 10 10
Smoking 9 9
Device Sensing Problem 9 9
Non Reproducible Results 9 10
Device Markings/Labelling Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 32245 32272
Hyperglycemia 1325 1329
Hypoglycemia 1228 1228
Dizziness 770 770
Insufficient Information 569 608
Shaking/Tremors 514 514
Loss of consciousness 493 493
Diaphoresis 404 404
No Consequences Or Impact To Patient 386 386
Fatigue 375 375
Headache 286 286
Blurred Vision 185 185
Nausea 148 148
Syncope/Fainting 139 139
Confusion/ Disorientation 137 137
Convulsion/Seizure 136 136
Muscle Weakness 134 134
Polydipsia 130 130
Lethargy 125 125
Presyncope 117 117
Vomiting 98 98
Urinary Frequency 89 89
Diabetic Ketoacidosis 75 75
Dysphasia 74 74
Malaise 61 61
Dry Mouth 60 60
Anxiety 57 57
Fall 42 42
Coma 40 40
Vertigo 35 35
Alteration in Body Temperature 33 33
Dehydration 33 33
Dyspnea 32 32
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 32
Pain 24 24
Tachycardia 23 23
Paresis 22 22
Chills 22 22
Cognitive Changes 22 22
Ambulation Difficulties 20 20
Numbness 19 19
Chest Pain 18 18
Abdominal Pain 17 17
Diarrhea 16 16
Visual Impairment 15 15
Pallor 15 15
Irritability 15 15
Speech Disorder 14 14
Extreme Exhaustion 14 14
Increased Appetite 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Ascensia Diabetes Care US, Inc. II Jul-20-2023
2 Cardinal Health Inc. II Jun-23-2021
3 Roche Diabetes Care, Inc. II Jun-21-2024
4 Roche Diabetes Care, Inc. II Aug-26-2021
5 Telcare, LLC II Mar-05-2025
6 Touch US Llc II Jul-26-2022
7 Trividia Health, Inc. I Mar-12-2026
8 Trividia Health, Inc. II Oct-30-2025
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