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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
VIVACHEK BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 10702 10702
2021 9196 9196
2022 8103 8103
2023 7262 7262
2024 6221 6221
2025 1294 1294

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 27181 27181
Incorrect, Inadequate or Imprecise Result or Readings 7023 7023
High Test Results 1900 1900
Display Difficult to Read 1484 1484
High Readings 856 856
Missing Test Results 625 625
Low Test Results 600 600
Image Display Error/Artifact 587 587
Device Displays Incorrect Message 433 433
Low Readings 336 336
Unable to Obtain Readings 274 274
Display or Visual Feedback Problem 222 222
Adverse Event Without Identified Device or Use Problem 197 197
Device Handling Problem 185 185
No Device Output 151 151
Erratic Results 147 147
Nonstandard Device 138 138
Insufficient Information 103 103
Application Program Problem: Dose Calculation Error 97 97
No Apparent Adverse Event 95 95
Power Problem 93 93
Product Quality Problem 68 68
Loss of Power 65 65
Battery Problem 61 61
Appropriate Term/Code Not Available 59 59
Device Alarm System 45 45
Incorrect Measurement 42 42
Output Problem 39 39
Unsealed Device Packaging 35 35
Premature Discharge of Battery 26 26
Melted 26 26
Failure to Calibrate 23 23
Incomplete or Missing Packaging 19 19
No Display/Image 19 19
Circuit Failure 17 17
Overheating of Device 16 16
Missing Information 14 14
Smoking 14 14
Material Twisted/Bent 13 13
Improper or Incorrect Procedure or Method 12 12
Therapeutic or Diagnostic Output Failure 12 12
Defective Device 12 12
Physical Resistance/Sticking 11 11
Use of Device Problem 10 10
Non Reproducible Results 10 10
Temperature Problem 10 10
Material Integrity Problem 9 9
Device Markings/Labelling Problem 9 9
Fire 9 9
Calibration Problem 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27830 27830
No Known Impact Or Consequence To Patient 6495 6495
No Consequences Or Impact To Patient 2550 2550
Hypoglycemia 1535 1535
Hyperglycemia 1376 1376
Dizziness 928 928
Shaking/Tremors 721 721
Loss of consciousness 603 603
Insufficient Information 556 556
Fatigue 437 437
Diaphoresis 424 424
Headache 331 331
Blurred Vision 249 249
Confusion/ Disorientation 225 225
Polydipsia 180 180
Nausea 174 174
Lethargy 170 170
Sweating 167 167
Convulsion/Seizure 144 144
Dysphasia 141 141
Syncope/Fainting 136 136
Urinary Frequency 135 135
Vomiting 121 121
Muscle Weakness 120 120
Presyncope 113 113
Diabetic Ketoacidosis 91 91
Weakness 76 76
Anxiety 74 74
Malaise 68 68
Coma 58 58
Dry Mouth 52 52
Fainting 51 51
Dehydration 48 48
Dyspnea 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
Seizures 30 30
Paresis 30 30
Chills 27 27
Ambulation Difficulties 27 27
Tachycardia 26 26
Syncope 24 24
Visual Impairment 24 24
Cognitive Changes 24 24
No Information 23 23
No Patient Involvement 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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