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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
1. K201880
MultiSure GK Link Blood Glucose and Ketone Monitor
...
2. K202534
MTM301 Blood Glucose and Ketone Monitoring System
3. K202885
GlucoSure HT Plus Blood Glucose Monitoring System
4. K212140
GlucoSure Link Blood Glucose Monitoring System
5. K213887
GAL-1A Plus Blood Glucose Monitoring System
6. K220421
BGM039 Blood Glucose Monitoring System, BGM039 Lin
...
7. K222234
GlucoSure ADVANCE Link Blood Glucose Monitoring Sy
...
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
1662
1662
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Power Up
29669
29669
Incorrect, Inadequate or Imprecise Result or Readings
11751
11751
High Test Results
2341
2341
Display Difficult to Read
1719
1719
High Readings
1001
1001
Low Test Results
732
732
Missing Test Results
679
679
Device Displays Incorrect Message
595
595
Image Display Error/Artifact
541
541
Unable to Obtain Readings
402
402
Low Readings
349
349
Adverse Event Without Identified Device or Use Problem
276
276
Device Handling Problem
217
217
No Device Output
196
196
Application Program Problem: Dose Calculation Error
147
147
Loss of Power
137
137
Nonstandard Device
117
117
Insufficient Information
114
114
Battery Problem
113
113
Appropriate Term/Code Not Available
98
98
Display or Visual Feedback Problem
98
98
No Apparent Adverse Event
92
92
Power Problem
71
71
Product Quality Problem
65
65
Device Alarm System
61
61
Unsealed Device Packaging
44
44
Incorrect Measurement
42
42
Therapeutic or Diagnostic Output Failure
38
38
Output Problem
33
33
Melted
32
32
Defective Device
31
31
Incomplete or Missing Packaging
30
30
Failure to Calibrate
28
28
No Display/Image
27
27
Premature Discharge of Battery
23
23
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
Overheating of Device
12
12
Smoking
12
12
Use of Device Problem
10
10
Break
10
10
Imprecision
10
10
Material Integrity Problem
10
10
Device Sensing Problem
9
9
Complete Loss of Power
9
9
Fire
9
9
Material Discolored
9
9
Non Reproducible Results
8
8
Sparking
8
8
Measurement System Incompatibility
8
8
Device Markings/Labelling Problem
8
8
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
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
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
Key or Button Unresponsive/not Working
4
4
Inaccurate Information
4
4
Packaging Problem
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Patient Data 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
Fitting Problem
2
2
Patient Device Interaction Problem
2
2
Explosion
2
2
Device Fell
2
2
Excessive Heating
2
2
Application Program Freezes, Becomes Nonfunctional
2
2
Intermittent Loss of Power
2
2
Flare or Flash
2
2
Detachment of Device or Device Component
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22577
22577
No Known Impact Or Consequence To Patient
14466
14466
No Consequences Or Impact To Patient
7173
7173
Hypoglycemia
1804
1804
Hyperglycemia
1485
1485
Dizziness
1164
1164
Shaking/Tremors
983
983
Loss of consciousness
670
670
Fatigue
502
502
Insufficient Information
492
492
Sweating
475
475
Headache
429
429
Diaphoresis
384
384
Blurred Vision
376
376
Confusion/ Disorientation
317
317
Polydipsia
278
278
Lethargy
219
219
Nausea
217
217
Urinary Frequency
210
210
Weakness
207
207
Dysphasia
152
152
Vomiting
145
145
Convulsion/Seizure
137
137
Fainting
130
130
Diabetic Ketoacidosis
106
106
Syncope/Fainting
105
105
Presyncope
103
103
Muscle Weakness
101
101
Malaise
96
96
No Code Available
93
93
No Information
90
90
Anxiety
84
84
Coma
70
70
Syncope
67
67
Seizures
64
64
Dyspnea
54
54
Dehydration
53
53
Fall
52
52
Vertigo
52
52
Chills
47
47
No Patient Involvement
45
45
Dry Mouth
45
45
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
34
34
Pain
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
Hot Flashes/Flushes
16
16
Memory Loss/Impairment
15
15
Extreme Exhaustion
15
15
Fever
14
14
Increased Appetite
12
12
Sleep Dysfunction
11
11
Collapse
10
10
Tingling
10
10
Not Applicable
10
10
Swelling/ Edema
9
9
Discomfort
9
9
Cramp(s)
8
8
Emotional Changes
8
8
Low Blood Pressure/ Hypotension
8
8
Patient Problem/Medical Problem
8
8
Balance Problems
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
Myalgia
6
6
Hypothermia
6
6
Pneumonia
6
6
Salivary Hypersecretion
6
6
Decreased Appetite
6
6
Hypoglycemic Shock
5
5
Hemorrhage/Bleeding
5
5
Anemia
5
5
Bruise/Contusion
5
5
Head Injury
5
5
Tinnitus
5
5
Twitching
5
5
Abdominal Cramps
5
5
Dyskinesia
4
4
Hypoesthesia
4
4
Bone Fracture(s)
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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