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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 5
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 1
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 1
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 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
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 4737 4737

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 37862 37862
Incorrect, Inadequate or Imprecise Resultor Readings 13316 13316
Device Displays Incorrect Message 10965 10965
Incorrect Or Inadequate Test Results 8779 8779
High Test Results 3897 3897
Loss of Power 2487 2487
Device Alarm System 1642 1642
Low Test Results 1400 1400
Display Difficult to Read 1356 1356
High Readings 1327 1327
Appropriate Term/Code Not Available 1112 1112
Device Operational Issue 1060 1060
Low Battery 852 852
Adverse Event Without Identified Device or Use Problem 844 844
Missing Test Results 746 746
No Display/Image 702 702
Battery Problem 672 672
Output Problem 567 567
Insufficient Information 484 484
Low Readings 435 435
Unable to Obtain Readings 416 416
No Device Output 412 412
Device Damaged Prior to Use 406 406
Image Display Error/Artifact 402 402
Device Inoperable 361 361
Electrical /Electronic Property Problem 360 360
Device Handling Problem 356 356
Component Missing 315 315
Image Resolution Poor 274 274
Device Operates Differently Than Expected 269 269
Application Program Problem: Dose Calculation Error 213 213
Sticking 190 190
Display or Visual Feedback Problem 168 168
Incorrect Software Programming Calculations 151 151
Break 145 145
Material Integrity Problem 137 137
Physical Property Issue 136 136
Defective Component 134 134
Failure to Calibrate 133 133
Off-Label Use 98 98
Crack 93 93
No Apparent Adverse Event 80 80
Material Discolored 74 74
Unsealed Device Packaging 73 73
Bent 69 69
Failure to Obtain Sample 67 67
Defective Device 63 63
Failure to Back-Up 62 62
Incorrect Measurement 56 56
Labelling, Instructions for Use or Training Problem 55 55
Product Quality Problem 52 52
Melted 51 51
Nonstandard Device 47 47
Improper or Incorrect Procedure or Method 46 46
Device Difficult to Setup or Prepare 44 44
Inadequate Instructions for Healthcare Professional 42 42
Incomplete or Missing Packaging 41 41
Computer Software Problem 40 40
Therapeutic or Diagnostic Output Failure 37 37
Data Problem 33 33
Power Problem 27 27
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 21 21
Premature Discharge of Battery 21 21
Invalid Sensing 20 20
Smoking 18 18
Material Twisted/Bent 16 16
Missing Information 15 15
Calibration Error 15 15
Imprecision 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Wireless Communication Problem 14 14
Physical Resistance/Sticking 13 13
Material Opacification 13 13
Thermal Decomposition of Device 13 13
Use of Device Problem 12 12
Calibration Problem 12 12
Communication or Transmission Problem 12 12
Device Stops Intermittently 11 11
Unexpected Therapeutic Results 11 11
Peeled/Delaminated 11 11
Complete Loss of Power 11 11
Packaging Problem 11 11
Circuit Failure 10 10
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 11995 11995
Hypoglycemia 2251 2251
Shaking/Tremors 1833 1833
Dizziness 1771 1771
Hyperglycemia 1651 1651
Sweating 1401 1401
Loss of consciousness 790 790
Fatigue 694 694
Headache 633 633
Blurred Vision 616 616
Confusion/ Disorientation 578 578
Weakness 566 566
Polydipsia 448 448
Urinary Frequency 367 367
Nausea 359 359
No Code Available 341 341
Lethargy 326 326
Fainting 324 324
Insufficient Information 291 291
Diaphoresis 235 235
No Information 221 221
Dysphasia 218 218
Vomiting 182 182
Syncope 162 162
Anxiety 153 153
Diabetic Ketoacidosis 150 150
Seizures 134 134
Malaise 117 117
Tachycardia 81 81
Fall 80 80
Coma 77 77
No Patient Involvement 77 77
Alteration In Body Temperature 74 74
Dyspnea 73 73
Vertigo 69 69
Convulsion/Seizure 67 67
Visual Impairment 65 65
Muscle Weakness 62 62
Dehydration 59 59
Cognitive Changes 59 59
Chills 58 58
Numbness 55 55
Palpitations 55 55
Syncope/Fainting 55 55
Ambulation Difficulties 54 54
Abdominal Pain 51 51
Presyncope 46 46
Chest Pain 42 42
Pain 41 41
Irritability 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Hot Flashes/Flushes 32 32
Paresis 30 30
Diarrhea 27 27
High Blood Pressure/ Hypertension 26 26
Patient Problem/Medical Problem 26 26
Tingling 25 25
Collapse 23 23
Memory Loss/Impairment 20 20
Extreme Exhaustion 20 20
Alteration in Body Temperature 20 20
Dry Mouth 18 18
Pallor 18 18
Visual Disturbances 17 17
Fever 16 16
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
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
Arthralgia 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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