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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
Product CodeNBW
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
AGAMATRIX
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 7
ARKRAY FACTORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSIA DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 4
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 2
HMD BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 5
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
SINOCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VIVACHEK BIOTECH (HANGZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VIVACHEK BIOTECH (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 14471 14471
2020 10702 10702
2021 9195 9195
2022 8103 8103
2023 7264 7264
2024 4278 4278

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 31352 31352
Incorrect, Inadequate or Imprecise Result or Readings 12058 12058
High Test Results 2484 2484
Display Difficult to Read 1771 1771
High Readings 1059 1059
Low Test Results 775 775
Missing Test Results 718 718
Device Displays Incorrect Message 612 612
Image Display Error/Artifact 583 583
Unable to Obtain Readings 417 417
Low Readings 372 372
Adverse Event Without Identified Device or Use Problem 279 279
Device Handling Problem 225 225
No Device Output 206 206
Display or Visual Feedback Problem 177 177
Application Program Problem: Dose Calculation Error 150 150
Loss of Power 137 137
Nonstandard Device 134 134
Insufficient Information 119 119
Battery Problem 114 114
Appropriate Term/Code Not Available 99 99
No Apparent Adverse Event 93 93
Power Problem 83 83
Product Quality Problem 68 68
Erratic Results 66 66
Device Alarm System 61 61
Incorrect Measurement 49 49
Unsealed Device Packaging 44 44
Therapeutic or Diagnostic Output Failure 38 38
Output Problem 36 36
Incomplete or Missing Packaging 34 34
Melted 33 33
Defective Device 32 32
Failure to Calibrate 30 30
No Display/Image 28 28
Premature Discharge of Battery 25 25
Physical Resistance/Sticking 17 17
Missing Information 16 16
Material Twisted/Bent 16 16
Circuit Failure 16 16
Defective Component 14 14
Wireless Communication Problem 13 13
Improper or Incorrect Procedure or Method 13 13
Overheating of Device 13 13
Smoking 12 12
Use of Device Problem 12 12
Imprecision 10 10
Break 10 10
Material Integrity Problem 10 10
Complete Loss of Power 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24887 24887
No Known Impact Or Consequence To Patient 14466 14466
No Consequences Or Impact To Patient 7173 7173
Hypoglycemia 1871 1871
Hyperglycemia 1572 1572
Dizziness 1199 1199
Shaking/Tremors 1009 1009
Loss of consciousness 716 716
Fatigue 535 535
Insufficient Information 519 519
Sweating 475 475
Headache 446 446
Diaphoresis 406 406
Blurred Vision 387 387
Confusion/ Disorientation 331 331
Polydipsia 284 284
Lethargy 229 229
Nausea 225 225
Urinary Frequency 218 218
Weakness 207 207
Dysphasia 167 167
Vomiting 150 150
Convulsion/Seizure 140 140
Fainting 130 130
Syncope/Fainting 113 113
Diabetic Ketoacidosis 110 110
Presyncope 109 109
Muscle Weakness 108 108
Malaise 98 98
No Code Available 93 93
No Information 90 90
Anxiety 89 89
Coma 71 71
Syncope 67 67
Seizures 64 64
Dehydration 57 57
Dyspnea 54 54
Fall 54 54
Vertigo 52 52
Dry Mouth 49 49
Chills 47 47
No Patient Involvement 45 45
Tachycardia 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Numbness 36 36
Visual Impairment 36 36
Cognitive Changes 36 36
Pain 35 35
Ambulation Difficulties 34 34
Paresis 33 33

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 Cambridge Sensors Limited II Aug-22-2019
4 Cardinal Health Inc. II Jun-23-2021
5 LABSTYLE INNOVATIONS II Oct-31-2019
6 Polymer Technology Systems, Inc. II Jan-21-2020
7 Polymer Technology Systems, Inc. II Dec-26-2019
8 Roche Diabetes Care, Inc. II Jun-21-2024
9 Roche Diabetes Care, Inc. II Aug-26-2021
10 Roche Diabetes Care, Inc. II Feb-05-2020
11 Roche Diabetes Care, Inc. II Dec-30-2019
12 Roche Diabetes Care, Inc. II Sep-30-2019
13 Touch US Llc II Jul-26-2022
14 Trividia Health, Inc. II Jun-01-2020
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