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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
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 1
BIOLAND TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIONIME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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
SINOCARE INC.
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 1662 1662

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 29669 29669
Incorrect, Inadequate or Imprecise Result or Readings 11751 11751
High Test Results 2341 2341
Display Difficult to Read 1719 1719
High Readings 1001 1001
Low Test Results 732 732
Missing Test Results 679 679
Device Displays Incorrect Message 595 595
Image Display Error/Artifact 541 541
Unable to Obtain Readings 402 402
Low Readings 349 349
Adverse Event Without Identified Device or Use Problem 276 276
Device Handling Problem 217 217
No Device Output 196 196
Application Program Problem: Dose Calculation Error 147 147
Loss of Power 137 137
Nonstandard Device 117 117
Insufficient Information 114 114
Battery Problem 113 113
Appropriate Term/Code Not Available 98 98
Display or Visual Feedback Problem 98 98
No Apparent Adverse Event 92 92
Power Problem 71 71
Product Quality Problem 65 65
Device Alarm System 61 61
Unsealed Device Packaging 44 44
Incorrect Measurement 42 42
Therapeutic or Diagnostic Output Failure 38 38
Output Problem 33 33
Melted 32 32
Defective Device 31 31
Incomplete or Missing Packaging 30 30
Failure to Calibrate 28 28
No Display/Image 27 27
Premature Discharge of Battery 23 23
Material Twisted/Bent 16 16
Missing Information 16 16
Circuit Failure 15 15
Defective Component 14 14
Physical Resistance/Sticking 14 14
Wireless Communication Problem 13 13
Improper or Incorrect Procedure or Method 13 13
Overheating of Device 12 12
Smoking 12 12
Use of Device Problem 10 10
Break 10 10
Imprecision 10 10
Material Integrity Problem 10 10
Device Sensing Problem 9 9
Complete Loss of Power 9 9
Fire 9 9
Material Discolored 9 9
Non Reproducible Results 8 8
Sparking 8 8
Measurement System Incompatibility 8 8
Device Markings/Labelling Problem 8 8
Erratic Results 7 7
Temperature Problem 7 7
Crack 7 7
Electrical /Electronic Property Problem 7 7
Device Damaged Prior to Use 6 6
Expiration Date Error 6 6
Protective Measures Problem 6 6
Inadequate User Interface 6 6
Charging Problem 6 6
Communication or Transmission Problem 6 6
Electrical Shorting 5 5
Data Problem 5 5
Device Contamination with Body Fluid 5 5
Labelling, Instructions for Use or Training Problem 5 5
Erratic or Intermittent Display 5 5
Use of Incorrect Control/Treatment Settings 4 4
Computer Software Problem 4 4
Mechanical Problem 4 4
Component Missing 4 4
Key or Button Unresponsive/not Working 4 4
Inaccurate Information 4 4
Packaging Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Patient Data Problem 3 3
Tear, Rip or Hole in Device Packaging 3 3
Off-Label Use 3 3
Failure to Charge 3 3
Failure to Back-Up 2 2
Thermal Decomposition of Device 2 2
Filling Problem 2 2
Material Fragmentation 2 2
Failure to Read Input Signal 2 2
Peeled/Delaminated 2 2
Failure to Obtain Sample 2 2
Structural Problem 2 2
Fitting Problem 2 2
Patient Device Interaction Problem 2 2
Explosion 2 2
Device Fell 2 2
Excessive Heating 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Intermittent Loss of Power 2 2
Flare or Flash 2 2
Detachment of Device or Device Component 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22577 22577
No Known Impact Or Consequence To Patient 14466 14466
No Consequences Or Impact To Patient 7173 7173
Hypoglycemia 1804 1804
Hyperglycemia 1485 1485
Dizziness 1164 1164
Shaking/Tremors 983 983
Loss of consciousness 670 670
Fatigue 502 502
Insufficient Information 492 492
Sweating 475 475
Headache 429 429
Diaphoresis 384 384
Blurred Vision 376 376
Confusion/ Disorientation 317 317
Polydipsia 278 278
Lethargy 219 219
Nausea 217 217
Urinary Frequency 210 210
Weakness 207 207
Dysphasia 152 152
Vomiting 145 145
Convulsion/Seizure 137 137
Fainting 130 130
Diabetic Ketoacidosis 106 106
Syncope/Fainting 105 105
Presyncope 103 103
Muscle Weakness 101 101
Malaise 96 96
No Code Available 93 93
No Information 90 90
Anxiety 84 84
Coma 70 70
Syncope 67 67
Seizures 64 64
Dyspnea 54 54
Dehydration 53 53
Fall 52 52
Vertigo 52 52
Chills 47 47
No Patient Involvement 45 45
Dry Mouth 45 45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Tachycardia 40 40
Visual Impairment 36 36
Cognitive Changes 35 35
Ambulation Difficulties 34 34
Numbness 34 34
Pain 34 34
Paresis 29 29
Chest Pain 28 28
Abdominal Pain 27 27
Alteration in Body Temperature 27 27
Alteration In Body Temperature 26 26
Irritability 22 22
Diarrhea 22 22
High Blood Pressure/ Hypertension 21 21
Pallor 20 20
Palpitations 19 19
Visual Disturbances 17 17
Hot Flashes/Flushes 16 16
Memory Loss/Impairment 15 15
Extreme Exhaustion 15 15
Fever 14 14
Increased Appetite 12 12
Sleep Dysfunction 11 11
Collapse 10 10
Tingling 10 10
Not Applicable 10 10
Swelling/ Edema 9 9
Discomfort 9 9
Cramp(s) 8 8
Emotional Changes 8 8
Low Blood Pressure/ Hypotension 8 8
Patient Problem/Medical Problem 8 8
Balance Problems 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Speech Disorder 7 7
Paresthesia 7 7
Unspecified Infection 7 7
Angina 7 7
Swelling 7 7
Loss of Vision 6 6
Myalgia 6 6
Hypothermia 6 6
Pneumonia 6 6
Salivary Hypersecretion 6 6
Decreased Appetite 6 6
Hypoglycemic Shock 5 5
Hemorrhage/Bleeding 5 5
Anemia 5 5
Bruise/Contusion 5 5
Head Injury 5 5
Tinnitus 5 5
Twitching 5 5
Abdominal Cramps 5 5
Dyskinesia 4 4
Hypoesthesia 4 4
Bone Fracture(s) 4 4
Deafness 4 4

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 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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