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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
  1.  K213061  SuperCheck Pro Blood Glucose Monitoring System
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 2322 2322

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 30125 30125
Incorrect, Inadequate or Imprecise Result or Readings 11837 11837
High Test Results 2366 2366
Display Difficult to Read 1734 1734
High Readings 1018 1018
Low Test Results 737 737
Missing Test Results 687 687
Device Displays Incorrect Message 595 595
Image Display Error/Artifact 552 552
Unable to Obtain Readings 406 406
Low Readings 358 358
Adverse Event Without Identified Device or Use Problem 276 276
Device Handling Problem 223 223
No Device Output 197 197
Application Program Problem: Dose Calculation Error 147 147
Loss of Power 137 137
Nonstandard Device 121 121
Insufficient Information 114 114
Battery Problem 113 113
Display or Visual Feedback Problem 101 101
Appropriate Term/Code Not Available 98 98
No Apparent Adverse Event 92 92
Power Problem 72 72
Product Quality Problem 66 66
Device Alarm System 61 61
Incorrect Measurement 47 47
Unsealed Device Packaging 44 44
Therapeutic or Diagnostic Output Failure 38 38
Output Problem 34 34
Melted 32 32
Defective Device 31 31
Failure to Calibrate 30 30
Incomplete or Missing Packaging 30 30
No Display/Image 27 27
Premature Discharge of Battery 24 24
Circuit Failure 16 16
Material Twisted/Bent 16 16
Missing Information 16 16
Physical Resistance/Sticking 15 15
Defective Component 14 14
Improper or Incorrect Procedure or Method 13 13
Wireless Communication Problem 13 13
Overheating of Device 12 12
Smoking 12 12
Use of Device Problem 11 11
Break 10 10
Imprecision 10 10
Material Integrity Problem 10 10
Complete Loss of Power 9 9
Non Reproducible Results 9 9
Device Sensing Problem 9 9
Fire 9 9
Material Discolored 9 9
Measurement System Incompatibility 8 8
Sparking 8 8
Device Markings/Labelling Problem 8 8
Communication or Transmission Problem 7 7
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
Data Problem 6 6
Charging Problem 6 6
Inadequate User Interface 6 6
Electrical Shorting 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
Packaging Problem 4 4
Key or Button Unresponsive/not Working 4 4
Inaccurate Information 4 4
Patient Data Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Calibration Problem 3 3
Fitting 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
No Audible Prompt/Feedback 2 2
Detachment of Device or Device Component 2 2
Loss of Data 2 2
Flare or Flash 2 2
Device-Device Incompatibility 2 2
Difficult to Open or Remove Packaging Material 2 2
Patient Device Interaction Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23151 23151
No Known Impact Or Consequence To Patient 14466 14466
No Consequences Or Impact To Patient 7173 7173
Hypoglycemia 1823 1823
Hyperglycemia 1513 1513
Dizziness 1174 1174
Shaking/Tremors 989 989
Loss of consciousness 680 680
Fatigue 516 516
Insufficient Information 497 497
Sweating 475 475
Headache 432 432
Diaphoresis 391 391
Blurred Vision 379 379
Confusion/ Disorientation 325 325
Polydipsia 283 283
Lethargy 222 222
Nausea 218 218
Urinary Frequency 214 214
Weakness 207 207
Dysphasia 159 159
Vomiting 145 145
Convulsion/Seizure 137 137
Fainting 130 130
Diabetic Ketoacidosis 106 106
Syncope/Fainting 105 105
Presyncope 104 104
Muscle Weakness 103 103
Malaise 98 98
No Code Available 93 93
No Information 90 90
Anxiety 85 85
Coma 71 71
Syncope 67 67
Seizures 64 64
Dehydration 55 55
Dyspnea 54 54
Fall 54 54
Vertigo 52 52
Chills 47 47
Dry Mouth 47 47
No Patient Involvement 45 45
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Tachycardia 40 40
Visual Impairment 36 36
Cognitive Changes 35 35
Pain 35 35
Ambulation Difficulties 34 34
Numbness 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
Extreme Exhaustion 17 17
Hot Flashes/Flushes 16 16
Memory Loss/Impairment 15 15
Fever 14 14
Increased Appetite 13 13
Sleep Dysfunction 11 11
Collapse 10 10
Tingling 10 10
Swelling/ Edema 10 10
Not Applicable 10 10
Discomfort 9 9
Emotional Changes 9 9
Low Blood Pressure/ Hypotension 8 8
Cramp(s) 8 8
Patient Problem/Medical Problem 8 8
Balance Problems 8 8
Speech Disorder 8 8
Paresthesia 8 8
Salivary Hypersecretion 8 8
Cramp(s) /Muscle Spasm(s) 8 8
Decreased Appetite 7 7
Swelling 7 7
Unspecified Infection 7 7
Angina 7 7
Hypothermia 6 6
Pneumonia 6 6
Loss of Vision 6 6
Myalgia 6 6
Tinnitus 5 5
Twitching 5 5
Abdominal Cramps 5 5
Head Injury 5 5
Hemorrhage/Bleeding 5 5
Anemia 5 5
Bruise/Contusion 5 5
Hypoglycemic Shock 5 5
Unspecified Eye / Vision Problem 5 5
Unspecified Gastrointestinal Problem 4 4
Aphonia 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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