• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 658 658

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 29054 29054
Incorrect, Inadequate or Imprecise Result or Readings 11572 11572
High Test Results 2291 2291
Display Difficult to Read 1676 1676
High Readings 974 974
Low Test Results 718 718
Missing Test Results 664 664
Device Displays Incorrect Message 585 585
Image Display Error/Artifact 526 526
Unable to Obtain Readings 400 400
Low Readings 341 341
Adverse Event Without Identified Device or Use Problem 268 268
Device Handling Problem 213 213
No Device Output 195 195
Application Program Problem: Dose Calculation Error 145 145
Loss of Power 137 137
Battery Problem 113 113
Insufficient Information 112 112
Nonstandard Device 112 112
Display or Visual Feedback Problem 98 98
Appropriate Term/Code Not Available 98 98
No Apparent Adverse Event 92 92
Power Problem 71 71
Product Quality Problem 62 62
Device Alarm System 61 61
Unsealed Device Packaging 42 42
Incorrect Measurement 41 41
Therapeutic or Diagnostic Output Failure 38 38
Output Problem 32 32
Defective Device 31 31
Melted 31 31
Incomplete or Missing Packaging 30 30
No Display/Image 27 27
Failure to Calibrate 26 26
Premature Discharge of Battery 18 18
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
Smoking 12 12
Use of Device Problem 10 10
Imprecision 10 10
Material Integrity Problem 10 10
Device Sensing Problem 9 9
Complete Loss of Power 9 9
Material Discolored 9 9
Break 9 9
Overheating of Device 9 9
Fire 9 9
Non Reproducible Results 8 8
Device Markings/Labelling Problem 8 8
Sparking 8 8
Measurement System Incompatibility 8 8
Erratic Results 7 7
Temperature Problem 7 7
Crack 7 7
Electrical /Electronic Property Problem 6 6
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
Erratic or Intermittent Display 5 5
Use of Incorrect Control/Treatment Settings 4 4
Computer Software Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Component Missing 4 4
Mechanical Problem 4 4
Inaccurate Information 4 4
Packaging Problem 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Key or Button Unresponsive/not Working 3 3
Tear, Rip or Hole in Device Packaging 3 3
Failure to Charge 3 3
Failure to Back-Up 2 2
Thermal Decomposition of Device 2 2
Filling Problem 2 2
Failure to Obtain Sample 2 2
Structural Problem 2 2
Peeled/Delaminated 2 2
Fitting Problem 2 2
Failure to Read Input Signal 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Patient Data Problem 2 2
Intermittent Loss of Power 2 2
Device Fell 2 2
Patient Device Interaction Problem 2 2
Explosion 2 2
Detachment of Device or Device Component 2 2
Flare or Flash 2 2
Calibration Problem 2 2
Loss of Data 2 2
Device-Device Incompatibility 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21716 21716
No Known Impact Or Consequence To Patient 14466 14466
No Consequences Or Impact To Patient 7173 7173
Hypoglycemia 1770 1770
Hyperglycemia 1441 1441
Dizziness 1146 1146
Shaking/Tremors 973 973
Loss of consciousness 646 646
Fatigue 491 491
Insufficient Information 483 483
Sweating 475 475
Headache 425 425
Blurred Vision 374 374
Diaphoresis 371 371
Confusion/ Disorientation 317 317
Polydipsia 274 274
Lethargy 211 211
Nausea 209 209
Urinary Frequency 208 208
Weakness 207 207
Dysphasia 150 150
Vomiting 138 138
Fainting 130 130
Convulsion/Seizure 127 127
Diabetic Ketoacidosis 104 104
Syncope/Fainting 101 101
Malaise 94 94
Muscle Weakness 94 94
No Code Available 93 93
Presyncope 91 91
No Information 90 90
Anxiety 84 84
Coma 67 67
Syncope 67 67
Seizures 64 64
Dyspnea 54 54
Fall 52 52
Vertigo 52 52
Dehydration 51 51
Chills 47 47
No Patient Involvement 45 45
Dry Mouth 42 42
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 33 33
Pain 33 33
Paresis 29 29
Chest Pain 28 28
Abdominal Pain 27 27
Alteration In Body Temperature 26 26
Alteration in Body Temperature 25 25
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
Fever 14 14
Extreme Exhaustion 13 13
Tingling 10 10
Sleep Dysfunction 10 10
Collapse 10 10
Not Applicable 10 10
Increased Appetite 10 10
Swelling/ Edema 9 9
Discomfort 9 9
Cramp(s) 8 8
Patient Problem/Medical Problem 8 8
Emotional Changes 8 8
Low Blood Pressure/ Hypotension 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
Hypothermia 6 6
Pneumonia 6 6
Balance Problems 6 6
Decreased Appetite 6 6
Salivary Hypersecretion 6 6
Hypoglycemic Shock 5 5
Hemorrhage/Bleeding 5 5
Anemia 5 5
Bruise/Contusion 5 5
Head Injury 5 5
Twitching 5 5
Myalgia 5 5
Abdominal Cramps 5 5
Dyskinesia 4 4
Hypoesthesia 4 4
Bone Fracture(s) 4 4
Deafness 4 4
Death 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
-
-