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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 4
ANDON HEALTH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
APEX BIOTECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 8
APPLIED BIOMEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ARKRAY FACTORY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ASCENSIA DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 3
ASCENSIA DIABETES CARE US INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
EPS BIO TECHNOLOGY CORP.
  SUBSTANTIALLY EQUIVALENT 3
FORACARE INC.
  SUBSTANTIALLY EQUIVALENT 1
HMD BIOMEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
I-SENS, INC.
  SUBSTANTIALLY EQUIVALENT 6
INTUITY MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LABSTYLE INNOVATION, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIFESCAN EUROPE GMBH
  SUBSTANTIALLY EQUIVALENT 1
LIVONGO HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROTECH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OK BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
TYSON BIORESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIVACHEK LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 16904 16904
2019 14471 14471
2020 10702 10702
2021 9195 9195
2022 8110 8110
2023 2619 2619

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 33204 33204
Incorrect, Inadequate or Imprecise Result or Readings 13762 13762
High Test Results 2841 2841
Incorrect Or Inadequate Test Results 2479 2479
Display Difficult to Read 1603 1603
High Readings 1264 1264
Device Operational Issue 1031 1031
Device Displays Incorrect Message 1013 1013
Low Test Results 913 913
Missing Test Results 691 691
Output Problem 557 557
Image Display Error/Artifact 478 478
Unable to Obtain Readings 470 470
Low Readings 419 419
Adverse Event Without Identified Device or Use Problem 407 407
No Device Output 396 396
Electrical /Electronic Property Problem 360 360
Device Inoperable 357 357
Device Handling Problem 290 290
Loss of Power 230 230
No Display/Image 213 213
Device Operates Differently Than Expected 198 198
Application Program Problem: Dose Calculation Error 197 197
Battery Problem 152 152
Appropriate Term/Code Not Available 149 149
Break 143 143
Material Integrity Problem 137 137
Physical Property Issue 136 136
Insufficient Information 112 112
Display or Visual Feedback Problem 111 111
No Apparent Adverse Event 84 84
Device Alarm System 75 75
Product Quality Problem 65 65
Nonstandard Device 57 57
Incorrect Measurement 50 50
Unsealed Device Packaging 50 50
Melted 40 40
Computer Software Problem 40 40
Power Problem 40 40
Therapeutic or Diagnostic Output Failure 36 36
Incorrect Software Programming Calculations 36 36
Defective Device 34 34
Failure to Calibrate 32 32
Incomplete or Missing Packaging 29 29
Computer Operating System Problem 24 24
Operating System Becomes Nonfunctional 24 24
Defective Component 23 23
Improper Device Output 22 22
Premature Discharge of Battery 20 20
Data Problem 19 19
Material Twisted/Bent 17 17
Improper or Incorrect Procedure or Method 17 17
Low Battery 16 16
Manufacturing, Packaging or Shipping Problem 15 15
Circuit Failure 15 15
Wireless Communication Problem 15 15
Missing Information 15 15
Smoking 14 14
Loss of Data 14 14
Physical Resistance/Sticking 13 13
Imprecision 12 12
Fire 11 11
Device Stops Intermittently 11 11
Packaging Problem 11 11
Complete Loss of Power 10 10
Application Program Problem 10 10
False Reading From Device Non-Compliance 10 10
Crack 9 9
Material Discolored 9 9
Failure to Obtain Sample 9 9
Device Sensing Problem 9 9
Measurement System Incompatibility 8 8
Use of Device Problem 8 8
Overheating of Device 8 8
Sparking 7 7
Inadequate User Interface 7 7
Protective Measures Problem 7 7
Erratic Results 6 6
Human Factors Issue 6 6
Human-Device Interface Problem 6 6
Electrical Shorting 6 6
Charging Problem 6 6
Communication or Transmission Problem 6 6
Device Difficult to Setup or Prepare 6 6
Mechanical Problem 5 5
Erratic or Intermittent Display 5 5
Moisture or Humidity Problem 5 5
Expiration Date Error 5 5
Component Missing 5 5
Temperature Problem 5 5
Unauthorized Access to Computer System 5 5
Non Reproducible Results 5 5
Inaccurate Information 4 4
Device Contamination with Body Fluid 4 4
Unexpected Therapeutic Results 4 4
Calibration Problem 4 4
Thermal Decomposition of Device 4 4
Labelling, Instructions for Use or Training Problem 4 4
Peeled/Delaminated 4 4
Poor Quality Image 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 25277 25277
No Clinical Signs, Symptoms or Conditions 17182 17182
No Consequences Or Impact To Patient 11143 11143
Hypoglycemia 2009 2009
Hyperglycemia 1547 1547
Dizziness 1408 1408
Shaking/Tremors 1291 1291
Sweating 851 851
Loss of consciousness 710 710
Fatigue 580 580
Headache 527 527
Blurred Vision 485 485
Confusion/ Disorientation 411 411
Insufficient Information 392 392
Polydipsia 364 364
Weakness 359 359
Diaphoresis 295 295
Nausea 278 278
Urinary Frequency 274 274
Lethargy 263 263
Fainting 203 203
Dysphasia 181 181
No Information 160 160
No Code Available 160 160
Vomiting 152 152
Diabetic Ketoacidosis 118 118
Syncope 116 116
Anxiety 111 111
Convulsion/Seizure 103 103
Malaise 100 100
Seizures 99 99
Muscle Weakness 88 88
Syncope/Fainting 70 70
Coma 69 69
Presyncope 66 66
Fall 60 60
Dyspnea 58 58
No Patient Involvement 58 58
Vertigo 56 56
Tachycardia 53 53
Dehydration 53 53
Chills 51 51
Alteration In Body Temperature 46 46
Numbness 45 45
Cognitive Changes 45 45
Ambulation Difficulties 41 41
Visual Impairment 41 41
Abdominal Pain 38 38
Pain 37 37
Palpitations 36 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Dry Mouth 34 34
Chest Pain 32 32
Paresis 31 31
High Blood Pressure/ Hypertension 24 24
Irritability 24 24
Diarrhea 22 22
Alteration in Body Temperature 22 22
Pallor 21 21
Hot Flashes/Flushes 20 20
Patient Problem/Medical Problem 20 20
Memory Loss/Impairment 17 17
Tingling 15 15
Visual Disturbances 15 15
Collapse 14 14
Fever 14 14
Extreme Exhaustion 13 13
Emotional Changes 12 12
Sleep Dysfunction 12 12
Cramp(s) 11 11
Swelling 10 10
Not Applicable 10 10
Shock, Insulin 9 9
Low Blood Pressure/ Hypotension 9 9
Hypothermia 8 8
Twitching 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Missing Value Reason 7 7
Increased Appetite 7 7
Swelling/ Edema 7 7
Loss of Vision 7 7
Discomfort 7 7
Blood Loss 7 7
Angina 7 7
Bone Fracture(s) 6 6
Incontinence 6 6
Pneumonia 6 6
Salivary Hypersecretion 6 6
Speech Disorder 6 6
Hypoglycemic Shock 5 5
Decreased Appetite 5 5
Paralysis 5 5
Unspecified Infection 5 5
Itching Sensation 5 5
Head Injury 5 5
Death 5 5
Anemia 5 5
Abdominal Cramps 5 5
Myalgia 5 5
Distress 4 4

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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