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TPLC
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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
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
1. K191657
Bioland Blood Glucose Monitoring System
2. K202739
Bioland G-425-2V Blood Glucose Monitoring System,
...
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
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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