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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
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 4811 4811

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 23640 23640
Incorrect, Inadequate or Imprecise Result or Readings 5097 5113
High Test Results 1565 1565
Display Difficult to Read 1116 1116
High Readings 640 651
Image Display Error/Artifact 571 571
Low Test Results 502 502
Missing Test Results 463 463
Low Readings 297 306
Display or Visual Feedback Problem 262 262
Unable to Obtain Readings 250 251
Device Displays Incorrect Message 228 238
Erratic Results 177 177
Nonstandard Device 154 154
Adverse Event Without Identified Device or Use Problem 143 144
Device Handling Problem 133 133
No Device Output 114 114
Power Problem 93 93
No Apparent Adverse Event 92 92
Insufficient Information 84 84
Product Quality Problem 83 89
Application Program Problem: Dose Calculation Error 57 57
Loss of Power 48 48
Appropriate Term/Code Not Available 42 42
Battery Problem 39 39
Device Alarm System 38 38
Unsealed Device Packaging 33 33
Incorrect Measurement 30 30
Output Problem 29 31
Failure to Calibrate 23 23
Premature Discharge of Battery 22 22
Melted 21 21
Defective Device 19 20
Overheating of Device 16 16
Therapeutic or Diagnostic Output Failure 16 36
Circuit Failure 13 14
No Display/Image 12 12
Physical Resistance/Sticking 11 11
Incomplete or Missing Packaging 11 11
Improper or Incorrect Procedure or Method 11 12
Missing Information 11 11
Temperature Problem 11 11
Use of Incorrect Control/Treatment Settings 10 10
Device Markings/Labelling Problem 9 9
Non Reproducible Results 9 10
Use of Device Problem 9 10
Calibration Problem 9 9
Smoking 9 9
Break 9 10
Labelling, Instructions for Use or Training Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30433 30460
Hyperglycemia 1280 1284
Hypoglycemia 1199 1199
Dizziness 749 749
Insufficient Information 542 581
Shaking/Tremors 507 507
Loss of consciousness 484 484
Diaphoresis 400 400
No Consequences Or Impact To Patient 386 386
Fatigue 360 360
Headache 280 280
Blurred Vision 184 184
Nausea 140 140
Syncope/Fainting 138 138
Convulsion/Seizure 137 137
Confusion/ Disorientation 135 135
Muscle Weakness 126 126
Polydipsia 126 126
Lethargy 124 124
Presyncope 116 116
Vomiting 97 97
Urinary Frequency 86 86
Dysphasia 74 74
Diabetic Ketoacidosis 71 71
Malaise 61 61
Dry Mouth 57 57
Anxiety 55 55
Coma 40 40
Fall 38 38
Vertigo 34 34
Alteration in Body Temperature 33 33
Dehydration 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Dyspnea 30 30
Pain 22 22
Cognitive Changes 22 22
Chills 22 22
Tachycardia 21 21
Paresis 20 20
Ambulation Difficulties 19 19
Numbness 18 18
Chest Pain 17 17
Abdominal Pain 17 17
Diarrhea 16 16
Irritability 15 15
Pallor 15 15
Visual Impairment 14 14
Extreme Exhaustion 14 14
Speech Disorder 13 13
Increased Appetite 12 12

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. II Oct-30-2025
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