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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 16903 16903
2019 14471 14471
2020 10702 10702
2021 9195 9195
2022 8105 8105

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 31420 31420
Incorrect, Inadequate or Imprecise Result or Readings 13385 13385
High Test Results 2715 2715
Incorrect Or Inadequate Test Results 2479 2479
Display Difficult to Read 1489 1489
High Readings 1213 1213
Device Operational Issue 1031 1031
Device Displays Incorrect Message 1007 1007
Low Test Results 887 887
Missing Test Results 654 654
Output Problem 557 557
Unable to Obtain Readings 441 441
Image Display Error/Artifact 441 441
Adverse Event Without Identified Device or Use Problem 404 404
Low Readings 400 400
No Device Output 386 386
Electrical /Electronic Property Problem 360 360
Device Inoperable 357 357
Device Handling Problem 288 288
Loss of Power 230 230
No Display/Image 212 212
Device Operates Differently Than Expected 198 198
Application Program Problem: Dose Calculation Error 194 194
Battery Problem 150 150
Appropriate Term/Code Not Available 147 147
Break 143 143
Material Integrity Problem 137 137
Physical Property Issue 136 136
Display or Visual Feedback Problem 104 104
Insufficient Information 97 97
No Apparent Adverse Event 83 83
Device Alarm System 75 75
Product Quality Problem 59 59
Nonstandard Device 51 51
Incorrect Measurement 49 49
Unsealed Device Packaging 49 49
Computer Software Problem 40 40
Melted 38 38
Therapeutic or Diagnostic Output Failure 36 36
Incorrect Software Programming Calculations 36 36
Power Problem 34 34
Defective Device 33 33
Failure to Calibrate 32 32
Incomplete or Missing Packaging 27 27
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
Improper or Incorrect Procedure or Method 17 17
Material Twisted/Bent 16 16
Low Battery 16 16
Circuit Failure 15 15
Missing Information 15 15
Loss of Data 14 14
Wireless Communication Problem 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Smoking 13 13
Physical Resistance/Sticking 13 13
Imprecision 12 12
Packaging Problem 11 11
Device Stops Intermittently 11 11
Application Program Problem 10 10
False Reading From Device Non-Compliance 10 10
Complete Loss of Power 10 10
Crack 9 9
Fire 9 9
Material Discolored 9 9
Device Sensing Problem 9 9
Failure to Obtain Sample 9 9
Measurement System Incompatibility 8 8
Overheating of Device 8 8
Use of Device Problem 7 7
Inadequate User Interface 7 7
Protective Measures Problem 7 7
Human Factors Issue 6 6
Human-Device Interface Problem 6 6
Communication or Transmission Problem 6 6
Sparking 6 6
Electrical Shorting 6 6
Device Difficult to Setup or Prepare 6 6
Temperature Problem 5 5
Erratic Results 5 5
Non Reproducible Results 5 5
Unauthorized Access to Computer System 5 5
Charging Problem 5 5
Device Contamination with Body Fluid 4 4
Peeled/Delaminated 4 4
Unexpected Therapeutic Results 4 4
Expiration Date Error 4 4
Moisture or Humidity Problem 4 4
Thermal Decomposition of Device 4 4
Mechanical Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Calibration Problem 4 4
Component Missing 4 4
Inaccurate Delivery 3 3
Failure to Charge 3 3
Calibration Error 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 14886 14886
No Consequences Or Impact To Patient 11143 11143
Hypoglycemia 1918 1918
Hyperglycemia 1448 1448
Dizziness 1345 1345
Shaking/Tremors 1265 1265
Sweating 851 851
Loss of consciousness 677 677
Fatigue 552 552
Headache 512 512
Blurred Vision 472 472
Confusion/ Disorientation 408 408
Weakness 359 359
Polydipsia 347 347
Insufficient Information 330 330
Diaphoresis 276 276
Nausea 272 272
Urinary Frequency 268 268
Lethargy 252 252
Fainting 203 203
Dysphasia 173 173
No Information 160 160
No Code Available 160 160
Vomiting 144 144
Syncope 116 116
Diabetic Ketoacidosis 116 116
Anxiety 111 111
Seizures 99 99
Malaise 94 94
Convulsion/Seizure 84 84
Muscle Weakness 76 76
Coma 67 67
Syncope/Fainting 63 63
Fall 59 59
Dyspnea 58 58
Presyncope 58 58
No Patient Involvement 58 58
Vertigo 56 56
Tachycardia 53 53
Chills 50 50
Dehydration 49 49
Alteration In Body Temperature 46 46
Numbness 42 42
Cognitive Changes 41 41
Visual Impairment 41 41
Ambulation Difficulties 39 39
Abdominal Pain 38 38
Palpitations 36 36
Pain 35 35
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Paresis 31 31
Chest Pain 31 31
Dry Mouth 28 28
High Blood Pressure/ Hypertension 24 24
Irritability 24 24
Alteration in Body Temperature 22 22
Diarrhea 21 21
Hot Flashes/Flushes 20 20
Patient Problem/Medical Problem 20 20
Pallor 19 19
Memory Loss/Impairment 17 17
Visual Disturbances 15 15
Tingling 15 15
Collapse 14 14
Fever 14 14
Emotional Changes 12 12
Sleep Dysfunction 12 12
Extreme Exhaustion 11 11
Cramp(s) 11 11
Swelling 10 10
Not Applicable 10 10
Shock, Insulin 9 9
Hypothermia 8 8
Twitching 8 8
Low Blood Pressure/ Hypotension 8 8
Loss of Vision 7 7
Missing Value Reason 7 7
Swelling/ Edema 7 7
Increased Appetite 7 7
Blood Loss 7 7
Salivary Hypersecretion 6 6
Angina 6 6
Incontinence 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Bone Fracture(s) 6 6
Death 5 5
Myalgia 5 5
Speech Disorder 5 5
Abdominal Cramps 5 5
Hypoglycemic Shock 5 5
Unspecified Infection 5 5
Itching Sensation 5 5
Head Injury 5 5
Pneumonia 5 5
Dyskinesia 4 4
Distress 4 4
Discomfort 4 4
Paralysis 4 4
Decreased Appetite 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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