Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
system, test, blood glucose, over the counter
Product Code
NBW
Regulation Number
862.1345
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
16904
16904
2019
14471
14471
2020
10702
10702
2021
9195
9195
2022
8110
8110
2023
2619
2619
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Power Up
33204
33204
Incorrect, Inadequate or Imprecise Result or Readings
13762
13762
High Test Results
2841
2841
Incorrect Or Inadequate Test Results
2479
2479
Display Difficult to Read
1603
1603
High Readings
1264
1264
Device Operational Issue
1031
1031
Device Displays Incorrect Message
1013
1013
Low Test Results
913
913
Missing Test Results
691
691
Output Problem
557
557
Image Display Error/Artifact
478
478
Unable to Obtain Readings
470
470
Low Readings
419
419
Adverse Event Without Identified Device or Use Problem
407
407
No Device Output
396
396
Electrical /Electronic Property Problem
360
360
Device Inoperable
357
357
Device Handling Problem
290
290
Loss of Power
230
230
No Display/Image
213
213
Device Operates Differently Than Expected
198
198
Application Program Problem: Dose Calculation Error
197
197
Battery Problem
152
152
Appropriate Term/Code Not Available
149
149
Break
143
143
Material Integrity Problem
137
137
Physical Property Issue
136
136
Insufficient Information
112
112
Display or Visual Feedback Problem
111
111
No Apparent Adverse Event
84
84
Device Alarm System
75
75
Product Quality Problem
65
65
Nonstandard Device
57
57
Incorrect Measurement
50
50
Unsealed Device Packaging
50
50
Melted
40
40
Computer Software Problem
40
40
Power Problem
40
40
Therapeutic or Diagnostic Output Failure
36
36
Incorrect Software Programming Calculations
36
36
Defective Device
34
34
Failure to Calibrate
32
32
Incomplete or Missing Packaging
29
29
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
Material Twisted/Bent
17
17
Improper or Incorrect Procedure or Method
17
17
Low Battery
16
16
Manufacturing, Packaging or Shipping Problem
15
15
Circuit Failure
15
15
Wireless Communication Problem
15
15
Missing Information
15
15
Smoking
14
14
Loss of Data
14
14
Physical Resistance/Sticking
13
13
Imprecision
12
12
Fire
11
11
Device Stops Intermittently
11
11
Packaging Problem
11
11
Complete Loss of Power
10
10
Application Program Problem
10
10
False Reading From Device Non-Compliance
10
10
Crack
9
9
Material Discolored
9
9
Failure to Obtain Sample
9
9
Device Sensing Problem
9
9
Measurement System Incompatibility
8
8
Use of Device Problem
8
8
Overheating of Device
8
8
Sparking
7
7
Inadequate User Interface
7
7
Protective Measures Problem
7
7
Erratic Results
6
6
Human Factors Issue
6
6
Human-Device Interface Problem
6
6
Electrical Shorting
6
6
Charging Problem
6
6
Communication or Transmission Problem
6
6
Device Difficult to Setup or Prepare
6
6
Mechanical Problem
5
5
Erratic or Intermittent Display
5
5
Moisture or Humidity Problem
5
5
Expiration Date Error
5
5
Component Missing
5
5
Temperature Problem
5
5
Unauthorized Access to Computer System
5
5
Non Reproducible Results
5
5
Inaccurate Information
4
4
Device Contamination with Body Fluid
4
4
Unexpected Therapeutic Results
4
4
Calibration Problem
4
4
Thermal Decomposition of Device
4
4
Labelling, Instructions for Use or Training Problem
4
4
Peeled/Delaminated
4
4
Poor Quality Image
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
17182
17182
No Consequences Or Impact To Patient
11143
11143
Hypoglycemia
2009
2009
Hyperglycemia
1547
1547
Dizziness
1408
1408
Shaking/Tremors
1291
1291
Sweating
851
851
Loss of consciousness
710
710
Fatigue
580
580
Headache
527
527
Blurred Vision
485
485
Confusion/ Disorientation
411
411
Insufficient Information
392
392
Polydipsia
364
364
Weakness
359
359
Diaphoresis
295
295
Nausea
278
278
Urinary Frequency
274
274
Lethargy
263
263
Fainting
203
203
Dysphasia
181
181
No Information
160
160
No Code Available
160
160
Vomiting
152
152
Diabetic Ketoacidosis
118
118
Syncope
116
116
Anxiety
111
111
Convulsion/Seizure
103
103
Malaise
100
100
Seizures
99
99
Muscle Weakness
88
88
Syncope/Fainting
70
70
Coma
69
69
Presyncope
66
66
Fall
60
60
Dyspnea
58
58
No Patient Involvement
58
58
Vertigo
56
56
Tachycardia
53
53
Dehydration
53
53
Chills
51
51
Alteration In Body Temperature
46
46
Numbness
45
45
Cognitive Changes
45
45
Ambulation Difficulties
41
41
Visual Impairment
41
41
Abdominal Pain
38
38
Pain
37
37
Palpitations
36
36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
35
35
Dry Mouth
34
34
Chest Pain
32
32
Paresis
31
31
High Blood Pressure/ Hypertension
24
24
Irritability
24
24
Diarrhea
22
22
Alteration in Body Temperature
22
22
Pallor
21
21
Hot Flashes/Flushes
20
20
Patient Problem/Medical Problem
20
20
Memory Loss/Impairment
17
17
Tingling
15
15
Visual Disturbances
15
15
Collapse
14
14
Fever
14
14
Extreme Exhaustion
13
13
Emotional Changes
12
12
Sleep Dysfunction
12
12
Cramp(s)
11
11
Swelling
10
10
Not Applicable
10
10
Shock, Insulin
9
9
Low Blood Pressure/ Hypotension
9
9
Hypothermia
8
8
Twitching
8
8
Cramp(s) /Muscle Spasm(s)
8
8
Missing Value Reason
7
7
Increased Appetite
7
7
Swelling/ Edema
7
7
Loss of Vision
7
7
Discomfort
7
7
Blood Loss
7
7
Angina
7
7
Bone Fracture(s)
6
6
Incontinence
6
6
Pneumonia
6
6
Salivary Hypersecretion
6
6
Speech Disorder
6
6
Hypoglycemic Shock
5
5
Decreased Appetite
5
5
Paralysis
5
5
Unspecified Infection
5
5
Itching Sensation
5
5
Head Injury
5
5
Death
5
5
Anemia
5
5
Abdominal Cramps
5
5
Myalgia
5
5
Distress
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
-
-