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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 7
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
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 6675 6675

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 39122 39122
Incorrect, Inadequate or Imprecise Result or Readings 13646 13646
Device Displays Incorrect Message 10979 10979
Incorrect Or Inadequate Test Results 8779 8779
High Test Results 3968 3968
Loss of Power 2491 2491
Device Alarm System 1644 1644
Display Difficult to Read 1444 1444
Low Test Results 1422 1422
High Readings 1360 1360
Appropriate Term/Code Not Available 1115 1115
Device Operational Issue 1060 1060
Low Battery 852 852
Adverse Event Without Identified Device or Use Problem 851 851
Missing Test Results 759 759
No Display/Image 703 703
Battery Problem 677 677
Output Problem 567 567
Insufficient Information 486 486
Low Readings 446 446
Unable to Obtain Readings 433 433
Image Display Error/Artifact 430 430
No Device Output 418 418
Device Damaged Prior to Use 406 406
Device Handling Problem 368 368
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 215 215
Sticking 190 190
Display or Visual Feedback Problem 174 174
Incorrect Software Programming Calculations 151 151
Break 145 145
Material Integrity Problem 137 137
Physical Property Issue 136 136
Failure to Calibrate 135 135
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
Failure to Back-Up 62 62
Product Quality Problem 61 61
Incorrect Measurement 57 57
Labelling, Instructions for Use or Training Problem 55 55
Melted 52 52
Nonstandard Device 48 48
Improper or Incorrect Procedure or Method 46 46
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
Data Problem 33 33
Power Problem 31 31
Operating System Becomes Nonfunctional 25 25
Premature Discharge of Battery 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 13641 13641
Hypoglycemia 2351 2351
Shaking/Tremors 1868 1868
Dizziness 1805 1805
Hyperglycemia 1730 1730
Sweating 1401 1401
Loss of consciousness 826 826
Fatigue 722 722
Headache 646 646
Blurred Vision 630 630
Confusion/ Disorientation 588 588
Weakness 566 566
Polydipsia 457 457
Urinary Frequency 375 375
Nausea 370 370
No Code Available 341 341
Lethargy 330 330
Fainting 324 324
Insufficient Information 314 314
Diaphoresis 273 273
No Information 221 221
Dysphasia 220 220
Vomiting 186 186
Syncope 162 162
Anxiety 160 160
Diabetic Ketoacidosis 154 154
Seizures 134 134
Malaise 119 119
Tachycardia 83 83
Fall 83 83
Coma 80 80
Dyspnea 77 77
No Patient Involvement 77 77
Convulsion/Seizure 75 75
Alteration In Body Temperature 74 74
Vertigo 74 74
Muscle Weakness 69 69
Visual Impairment 65 65
Dehydration 62 62
Chills 60 60
Syncope/Fainting 60 60
Cognitive Changes 59 59
Numbness 57 57
Palpitations 55 55
Ambulation Difficulties 54 54
Presyncope 54 54
Abdominal Pain 51 51
Chest Pain 42 42
Pain 41 41
Irritability 38 38
Paresis 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Hot Flashes/Flushes 32 32
Diarrhea 29 29
High Blood Pressure/ Hypertension 26 26
Patient Problem/Medical Problem 26 26
Dry Mouth 25 25
Tingling 25 25
Collapse 23 23
Alteration in Body Temperature 22 22
Memory Loss/Impairment 20 20
Extreme Exhaustion 20 20
Pallor 18 18
Visual Disturbances 17 17
Fever 17 17
Emotional Changes 15 15
Shock, Insulin 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
Hypothermia 8 8
Incontinence 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
Cramp(s) /Muscle Spasm(s) 6 6
Burning Sensation 6 6
Low Blood Pressure/ Hypotension 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
Myalgia 5 5
Renal Failure 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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