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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 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
  1.  K213131  Accu-Chek Guide Solo diabetes manager blood glucos ...
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 10703 10734
2021 9198 9227
2022 8103 8138
2023 7256 7256
2024 6220 6220
2025 4087 4087

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 29286 29286
Incorrect, Inadequate or Imprecise Result or Readings 7233 7253
High Test Results 2036 2036
Display Difficult to Read 1486 1486
High Readings 929 940
Missing Test Results 654 654
Image Display Error/Artifact 651 651
Low Test Results 638 638
Device Displays Incorrect Message 441 462
Low Readings 379 388
Unable to Obtain Readings 279 285
Display or Visual Feedback Problem 260 260
Adverse Event Without Identified Device or Use Problem 202 202
Device Handling Problem 191 191
Erratic Results 164 164
Nonstandard Device 161 161
No Device Output 152 152
Insufficient Information 110 110
Power Problem 99 99
No Apparent Adverse Event 98 98
Application Program Problem: Dose Calculation Error 97 97
Product Quality Problem 90 96
Loss of Power 65 65
Appropriate Term/Code Not Available 63 63
Battery Problem 62 62
Device Alarm System 50 50
Unsealed Device Packaging 44 44
Incorrect Measurement 44 44
Output Problem 43 45
Melted 28 28
Premature Discharge of Battery 26 27
Failure to Calibrate 23 23
No Display/Image 20 20
Incomplete or Missing Packaging 19 19
Overheating of Device 19 19
Defective Device 19 20
Therapeutic or Diagnostic Output Failure 18 42
Circuit Failure 17 17
Smoking 15 15
Missing Information 14 14
Material Twisted/Bent 14 14
Non Reproducible Results 12 12
Use of Device Problem 12 13
Improper or Incorrect Procedure or Method 12 13
Physical Resistance/Sticking 11 11
Calibration Problem 11 11
Temperature Problem 11 11
Device Markings/Labelling Problem 10 10
Fire 10 10
Material Integrity Problem 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30344 30370
No Known Impact Or Consequence To Patient 6495 6517
No Consequences Or Impact To Patient 2550 2550
Hypoglycemia 1580 1580
Hyperglycemia 1470 1474
Dizziness 980 980
Shaking/Tremors 731 731
Loss of consciousness 619 619
Insufficient Information 588 630
Fatigue 456 456
Diaphoresis 437 437
Headache 346 346
Blurred Vision 261 261
Confusion/ Disorientation 239 239
Polydipsia 185 185
Nausea 180 180
Lethargy 172 172
Sweating 167 167
Syncope/Fainting 148 148
Convulsion/Seizure 145 145
Dysphasia 143 143
Urinary Frequency 139 139
Muscle Weakness 130 130
Presyncope 127 127
Vomiting 123 123
Diabetic Ketoacidosis 93 93
Weakness 76 76
Malaise 76 76
Anxiety 74 74
Dry Mouth 59 59
Coma 58 58
Fainting 51 51
Dyspnea 49 49
Dehydration 48 48
Fall 46 46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Vertigo 39 39
No Code Available 34 34
Alteration in Body Temperature 33 33
Pain 31 31
Paresis 30 30
Seizures 30 30
Chills 28 28
Ambulation Difficulties 27 27
Tachycardia 26 26
Visual Impairment 24 24
Syncope 24 24
Cognitive Changes 24 24
No Patient Involvement 23 23
Abdominal Pain 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 Oct-30-2025
11 Trividia Health, Inc. II Jun-01-2020
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