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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
ABBOTT DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
ACON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ALL MEDICUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANDON HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
APEX BIO TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 1
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 8
APPLIED BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ARKRAY FACTORY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENSIA DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 3
ASCENSIA DIABETES CARE US INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
  1.  K161790  iGlucose Blood Glucose Monitoring System
  2.  K170143  GE Blood Glucose Monitoring System 180, GE Blood G ...
  3.  K173139  Rightest Blood Glucose Monitoring System Wiz, Righ ...
  4.  K173638  Rightest Blood Glucose Monitoring System Max, Righ ...
  5.  K190564  Rightest Blood Glucose Monitoring System GM700S, R ...
BIOTEST MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
EPS BIO TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 3
FORACARE INC.
  SUBSTANTIALLY EQUIVALENT 1
HMD BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 8
INTUITY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
IXENSOR COMPANY LTD.
  SUBSTANTIALLY EQUIVALENT 1
LABSTYLE INNOVATION, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LABSTYLE INNOVATIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFESCAN EUROPE GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIVONGO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTECH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OK BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
OSANG HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
POLYMER TECHNOLOGY SYSTEMS, INC. D/B/A PTS DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
SD BIOSENSOR
  SUBSTANTIALLY EQUIVALENT 1
SINOCARE MEDITECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN EMPECS MEDICAL DEVICE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
TYSON BIORESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 3
VIVACHEK LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 37536 37536
2018 16903 16903
2019 14471 14471
2020 10702 10702
2021 9195 9195
2022 8105 8105

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 40132 40132
Incorrect, Inadequate or Imprecise Result or Readings 13841 13841
Device Displays Incorrect Message 10985 10985
Incorrect Or Inadequate Test Results 8779 8779
High Test Results 4014 4014
Loss of Power 2495 2495
Device Alarm System 1644 1644
Display Difficult to Read 1492 1492
Low Test Results 1441 1441
High Readings 1391 1391
Appropriate Term/Code Not Available 1116 1116
Device Operational Issue 1060 1060
Adverse Event Without Identified Device or Use Problem 854 854
Low Battery 852 852
Missing Test Results 769 769
No Display/Image 703 703
Battery Problem 677 677
Output Problem 567 567
Insufficient Information 488 488
Low Readings 460 460
Image Display Error/Artifact 451 451
Unable to Obtain Readings 447 447
No Device Output 423 423
Device Damaged Prior to Use 406 406
Device Handling Problem 374 374
Device Inoperable 361 361
Electrical /Electronic Property Problem 360 360
Component Missing 315 315
Image Resolution Poor 274 274
Device Operates Differently Than Expected 269 269
Application Program Problem: Dose Calculation Error 216 216
Sticking 190 190
Display or Visual Feedback Problem 176 176
Incorrect Software Programming Calculations 151 151
Break 145 145
Failure to Calibrate 139 139
Material Integrity Problem 137 137
Physical Property Issue 136 136
Defective Component 134 134
Off-Label Use 98 98
Crack 93 93
No Apparent Adverse Event 84 84
Unsealed Device Packaging 76 76
Material Discolored 74 74
Bent 69 69
Failure to Obtain Sample 67 67
Defective Device 63 63
Product Quality Problem 63 63
Failure to Back-Up 62 62
Incorrect Measurement 58 58
Labelling, Instructions for Use or Training Problem 55 55
Melted 52 52
Nonstandard Device 51 51
Improper or Incorrect Procedure or Method 47 47
Device Difficult to Setup or Prepare 44 44
Computer Software Problem 43 43
Inadequate Instructions for Healthcare Professional 42 42
Incomplete or Missing Packaging 41 41
Therapeutic or Diagnostic Output Failure 37 37
Power Problem 34 34
Data Problem 33 33
Premature Discharge of Battery 26 26
Operating System Becomes Nonfunctional 25 25
False Reading From Device Non-Compliance 24 24
Computer Operating System Problem 24 24
Improper Device Output 23 23
Loss of Data 22 22
Erratic or Intermittent Display 22 22
Invalid Sensing 20 20
Smoking 18 18
Material Twisted/Bent 16 16
Missing Information 15 15
Calibration Error 15 15
Circuit Failure 15 15
Imprecision 14 14
Wireless Communication Problem 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Physical Resistance/Sticking 13 13
Material Opacification 13 13
Thermal Decomposition of Device 13 13
Use of Device Problem 12 12
Communication or Transmission Problem 12 12
Calibration Problem 12 12
Unexpected Therapeutic Results 11 11
Device Stops Intermittently 11 11
Peeled/Delaminated 11 11
Complete Loss of Power 11 11
Packaging Problem 11 11
Fire 10 10
Application Program Problem 10 10
Device Sensing Problem 10 10
Measurement System Incompatibility 9 9
Electrical Shorting 8 8
Overheating of Device 8 8
Date/Time-Related Software Problem 7 7
Device Issue 7 7
Inadequate User Interface 7 7
Protective Measures Problem 7 7
Temperature Problem 6 6
Patient Data Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 36038 36038
No Consequences Or Impact To Patient 35073 35073
No Clinical Signs, Symptoms or Conditions 14887 14887
Hypoglycemia 2404 2404
Shaking/Tremors 1880 1880
Dizziness 1839 1839
Hyperglycemia 1785 1785
Sweating 1401 1401
Loss of consciousness 848 848
Fatigue 731 731
Headache 660 660
Blurred Vision 637 637
Confusion/ Disorientation 593 593
Weakness 566 566
Polydipsia 464 464
Urinary Frequency 378 378
Nausea 375 375
No Code Available 341 341
Lethargy 331 331
Insufficient Information 330 330
Fainting 324 324
Diaphoresis 286 286
Dysphasia 222 222
No Information 221 221
Vomiting 186 186
Syncope 162 162
Anxiety 161 161
Diabetic Ketoacidosis 157 157
Seizures 134 134
Malaise 123 123
Tachycardia 85 85
Fall 84 84
Convulsion/Seizure 84 84
Coma 81 81
Muscle Weakness 78 78
Dyspnea 77 77
No Patient Involvement 77 77
Alteration In Body Temperature 74 74
Vertigo 74 74
Visual Impairment 67 67
Dehydration 64 64
Syncope/Fainting 63 63
Chills 60 60
Cognitive Changes 59 59
Presyncope 58 58
Numbness 57 57
Ambulation Difficulties 56 56
Palpitations 55 55
Abdominal Pain 54 54
Chest Pain 42 42
Pain 42 42
Irritability 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Paresis 34 34
Hot Flashes/Flushes 33 33
Diarrhea 29 29
Dry Mouth 28 28
High Blood Pressure/ Hypertension 27 27
Patient Problem/Medical Problem 26 26
Tingling 25 25
Collapse 23 23
Alteration in Body Temperature 22 22
Pallor 20 20
Memory Loss/Impairment 20 20
Extreme Exhaustion 20 20
Fever 19 19
Visual Disturbances 17 17
Shock, Insulin 15 15
Emotional Changes 15 15
Loss of Vision 14 14
Cramp(s) 13 13
Sleep Dysfunction 13 13
Swelling 11 11
Not Applicable 11 11
Twitching 10 10
Death 10 10
Missing Value Reason 9 9
Itching Sensation 8 8
Incontinence 8 8
Low Blood Pressure/ Hypotension 8 8
Hypothermia 8 8
Bone Fracture(s) 8 8
Head Injury 8 8
Unspecified Infection 7 7
Abdominal Cramps 7 7
Distress 7 7
Complaint, Ill-Defined 7 7
Blood Loss 7 7
Increased Appetite 7 7
Swelling/ Edema 7 7
Salivary Hypersecretion 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Burning Sensation 6 6
Pneumonia 6 6
Angina 6 6
Dysphagia/ Odynophagia 5 5
Eye Injury 5 5
Paralysis 5 5
Neuropathy 5 5
Vitreous Floaters 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Feb-28-2020
2 Cambridge Sensors Limited II Aug-22-2019
3 Cardinal Health Inc. II Jun-23-2021
4 LABSTYLE INNOVATIONS II Oct-31-2019
5 Polymer Technology Systems, Inc. II Jan-21-2020
6 Polymer Technology Systems, Inc. II Dec-26-2019
7 Polymer Technology Systems, Inc. II Apr-28-2018
8 Roche Diabetes Care, Inc. II Aug-26-2021
9 Roche Diabetes Care, Inc. II Feb-05-2020
10 Roche Diabetes Care, Inc. II Dec-30-2019
11 Roche Diabetes Care, Inc. II Sep-30-2019
12 Touch US Llc II Jul-26-2022
13 Trividia Health, Inc. II Jun-01-2020
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