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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 3
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
SEJOY BIOMEDICAL CO., LTD
  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 5735 5735

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 32404 32404
Incorrect, Inadequate or Imprecise Result or Readings 12125 12125
High Test Results 2560 2560
Display Difficult to Read 1774 1774
High Readings 1087 1087
Low Test Results 810 810
Missing Test Results 734 734
Image Display Error/Artifact 626 626
Device Displays Incorrect Message 617 617
Unable to Obtain Readings 421 421
Low Readings 382 382
Adverse Event Without Identified Device or Use Problem 283 283
Device Handling Problem 233 233
No Device Output 207 207
Display or Visual Feedback Problem 205 205
Application Program Problem: Dose Calculation Error 150 150
Nonstandard Device 141 141
Loss of Power 137 137
Erratic Results 125 125
Insufficient Information 120 120
Battery Problem 114 114
Appropriate Term/Code Not Available 100 100
No Apparent Adverse Event 96 96
Power Problem 87 87
Product Quality Problem 69 69
Device Alarm System 65 65
Incorrect Measurement 49 49
Unsealed Device Packaging 45 45
Output Problem 38 38
Therapeutic or Diagnostic Output Failure 38 38
Incomplete or Missing Packaging 35 35
Melted 33 33
Failure to Calibrate 32 32
Defective Device 32 32
No Display/Image 29 29
Premature Discharge of Battery 26 26
Physical Resistance/Sticking 18 18
Missing Information 16 16
Material Twisted/Bent 16 16
Circuit Failure 16 16
Defective Component 15 15
Overheating of Device 14 14
Wireless Communication Problem 13 13
Smoking 13 13
Improper or Incorrect Procedure or Method 13 13
Use of Device Problem 12 12
Imprecision 10 10
Fire 10 10
Break 10 10
Material Integrity Problem 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26198 26198
No Known Impact Or Consequence To Patient 14466 14466
No Consequences Or Impact To Patient 7173 7173
Hypoglycemia 1902 1902
Hyperglycemia 1613 1613
Dizziness 1226 1226
Shaking/Tremors 1022 1022
Loss of consciousness 726 726
Fatigue 553 553
Insufficient Information 531 531
Sweating 475 475
Headache 457 457
Diaphoresis 418 418
Blurred Vision 392 392
Confusion/ Disorientation 333 333
Polydipsia 288 288
Lethargy 233 233
Nausea 232 232
Urinary Frequency 223 223
Weakness 207 207
Dysphasia 169 169
Vomiting 163 163
Convulsion/Seizure 140 140
Fainting 130 130
Syncope/Fainting 125 125
Muscle Weakness 116 116
Diabetic Ketoacidosis 112 112
Presyncope 111 111
Malaise 98 98
No Code Available 93 93
Anxiety 91 91
No Information 90 90
Coma 71 71
Syncope 67 67
Seizures 64 64
Dehydration 58 58
Fall 56 56
Dyspnea 56 56
Vertigo 52 52
Dry Mouth 50 50
Chills 48 48
No Patient Involvement 45 45
Tachycardia 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Numbness 38 38
Pain 37 37
Visual Impairment 36 36
Ambulation Difficulties 36 36
Cognitive Changes 36 36
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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