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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
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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