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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
ABBOTT DIABETES CARE INC.
SUBSTANTIALLY EQUIVALENT
1
ACON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
4
ALL MEDICUS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ANDON HEALTH CO., LTD
SUBSTANTIALLY EQUIVALENT
3
APEX BIO TECHNOLOGY CORP.
SUBSTANTIALLY EQUIVALENT
1
APEX BIOTECHNOLOGY CORP.
SUBSTANTIALLY EQUIVALENT
5
APPLIED BIOMEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
ARKRAY FACTORY, INC.
SUBSTANTIALLY EQUIVALENT
2
ASCENSIA DIABETES CARE
SUBSTANTIALLY EQUIVALENT
3
ASCENSIA DIABETES CARE US INC.
SUBSTANTIALLY EQUIVALENT
1
BIOLAND TECHNOLOGY LTD.
SUBSTANTIALLY EQUIVALENT
2
BIONIME CORPORATION
SUBSTANTIALLY EQUIVALENT
5
BIOTEST MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
EPS BIO TECHNOLOGY CORP.
SUBSTANTIALLY EQUIVALENT
3
FORACARE INC.
SUBSTANTIALLY EQUIVALENT
1
HMD BIOMEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
I-SENS, INC.
SUBSTANTIALLY EQUIVALENT
8
INTUITY MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
IXENSOR COMPANY LTD.
SUBSTANTIALLY EQUIVALENT
1
LABSTYLE INNOVATION, LTD.
SUBSTANTIALLY EQUIVALENT
1
LABSTYLE INNOVATIONS, LTD.
SUBSTANTIALLY EQUIVALENT
1
LIFESCAN EUROPE GMBH
SUBSTANTIALLY EQUIVALENT
1
LIVONGO HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
MICROTECH MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
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
SD BIOSENSOR
SUBSTANTIALLY EQUIVALENT
1
SINOCARE MEDITECH, INC.
SUBSTANTIALLY EQUIVALENT
1
TAIDOC TECHNOLOGY CORPORATION
SUBSTANTIALLY EQUIVALENT
5
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
TIANJIN EMPECS MEDICAL DEVICE CO.,LTD.
SUBSTANTIALLY EQUIVALENT
1
TYSON BIORESEARCH, INC.
SUBSTANTIALLY EQUIVALENT
3
VIVACHEK LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2017
37536
37536
2018
16903
16903
2019
14471
14471
2020
10702
10702
2021
9195
9195
2022
4737
4737
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Power Up
37862
37862
Incorrect, Inadequate or Imprecise Resultor Readings
13316
13316
Device Displays Incorrect Message
10965
10965
Incorrect Or Inadequate Test Results
8779
8779
High Test Results
3897
3897
Loss of Power
2487
2487
Device Alarm System
1642
1642
Low Test Results
1400
1400
Display Difficult to Read
1356
1356
High Readings
1327
1327
Appropriate Term/Code Not Available
1112
1112
Device Operational Issue
1060
1060
Low Battery
852
852
Adverse Event Without Identified Device or Use Problem
844
844
Missing Test Results
746
746
No Display/Image
702
702
Battery Problem
672
672
Output Problem
567
567
Insufficient Information
484
484
Low Readings
435
435
Unable to Obtain Readings
416
416
No Device Output
412
412
Device Damaged Prior to Use
406
406
Image Display Error/Artifact
402
402
Device Inoperable
361
361
Electrical /Electronic Property Problem
360
360
Device Handling Problem
356
356
Component Missing
315
315
Image Resolution Poor
274
274
Device Operates Differently Than Expected
269
269
Application Program Problem: Dose Calculation Error
213
213
Sticking
190
190
Display or Visual Feedback Problem
168
168
Incorrect Software Programming Calculations
151
151
Break
145
145
Material Integrity Problem
137
137
Physical Property Issue
136
136
Defective Component
134
134
Failure to Calibrate
133
133
Off-Label Use
98
98
Crack
93
93
No Apparent Adverse Event
80
80
Material Discolored
74
74
Unsealed Device Packaging
73
73
Bent
69
69
Failure to Obtain Sample
67
67
Defective Device
63
63
Failure to Back-Up
62
62
Incorrect Measurement
56
56
Labelling, Instructions for Use or Training Problem
55
55
Product Quality Problem
52
52
Melted
51
51
Nonstandard Device
47
47
Improper or Incorrect Procedure or Method
46
46
Device Difficult to Setup or Prepare
44
44
Inadequate Instructions for Healthcare Professional
42
42
Incomplete or Missing Packaging
41
41
Computer Software Problem
40
40
Therapeutic or Diagnostic Output Failure
37
37
Data Problem
33
33
Power Problem
27
27
Operating System Becomes Nonfunctional
25
25
False Reading From Device Non-Compliance
24
24
Computer Operating System Problem
24
24
Improper Device Output
23
23
Loss of Data
22
22
Erratic or Intermittent Display
21
21
Premature Discharge of Battery
21
21
Invalid Sensing
20
20
Smoking
18
18
Material Twisted/Bent
16
16
Missing Information
15
15
Calibration Error
15
15
Imprecision
14
14
Manufacturing, Packaging or Shipping Problem
14
14
Wireless Communication Problem
14
14
Physical Resistance/Sticking
13
13
Material Opacification
13
13
Thermal Decomposition of Device
13
13
Use of Device Problem
12
12
Calibration Problem
12
12
Communication or Transmission Problem
12
12
Device Stops Intermittently
11
11
Unexpected Therapeutic Results
11
11
Peeled/Delaminated
11
11
Complete Loss of Power
11
11
Packaging Problem
11
11
Circuit Failure
10
10
Fire
10
10
Application Program Problem
10
10
Device Sensing Problem
10
10
Measurement System Incompatibility
9
9
Electrical Shorting
8
8
Overheating of Device
8
8
Date/Time-Related Software Problem
7
7
Device Issue
7
7
Inadequate User Interface
7
7
Protective Measures Problem
7
7
Temperature Problem
6
6
Patient Data Problem
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
36038
36038
No Consequences Or Impact To Patient
35073
35073
No Clinical Signs, Symptoms or Conditions
11995
11995
Hypoglycemia
2251
2251
Shaking/Tremors
1833
1833
Dizziness
1771
1771
Hyperglycemia
1651
1651
Sweating
1401
1401
Loss of consciousness
790
790
Fatigue
694
694
Headache
633
633
Blurred Vision
616
616
Confusion/ Disorientation
578
578
Weakness
566
566
Polydipsia
448
448
Urinary Frequency
367
367
Nausea
359
359
No Code Available
341
341
Lethargy
326
326
Fainting
324
324
Insufficient Information
291
291
Diaphoresis
235
235
No Information
221
221
Dysphasia
218
218
Vomiting
182
182
Syncope
162
162
Anxiety
153
153
Diabetic Ketoacidosis
150
150
Seizures
134
134
Malaise
117
117
Tachycardia
81
81
Fall
80
80
Coma
77
77
No Patient Involvement
77
77
Alteration In Body Temperature
74
74
Dyspnea
73
73
Vertigo
69
69
Convulsion/Seizure
67
67
Visual Impairment
65
65
Muscle Weakness
62
62
Dehydration
59
59
Cognitive Changes
59
59
Chills
58
58
Numbness
55
55
Palpitations
55
55
Syncope/Fainting
55
55
Ambulation Difficulties
54
54
Abdominal Pain
51
51
Presyncope
46
46
Chest Pain
42
42
Pain
41
41
Irritability
38
38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
33
33
Hot Flashes/Flushes
32
32
Paresis
30
30
Diarrhea
27
27
High Blood Pressure/ Hypertension
26
26
Patient Problem/Medical Problem
26
26
Tingling
25
25
Collapse
23
23
Memory Loss/Impairment
20
20
Extreme Exhaustion
20
20
Alteration in Body Temperature
20
20
Dry Mouth
18
18
Pallor
18
18
Visual Disturbances
17
17
Fever
16
16
Emotional Changes
15
15
Shock, Insulin
15
15
Loss of Vision
14
14
Cramp(s)
13
13
Sleep Dysfunction
13
13
Swelling
11
11
Not Applicable
11
11
Twitching
10
10
Death
10
10
Missing Value Reason
9
9
Itching Sensation
8
8
Hypothermia
8
8
Incontinence
8
8
Bone Fracture(s)
8
8
Head Injury
8
8
Unspecified Infection
7
7
Abdominal Cramps
7
7
Distress
7
7
Complaint, Ill-Defined
7
7
Blood Loss
7
7
Increased Appetite
7
7
Burning Sensation
6
6
Low Blood Pressure/ Hypotension
6
6
Pneumonia
6
6
Angina
6
6
Dysphagia/ Odynophagia
5
5
Eye Injury
5
5
Paralysis
5
5
Neuropathy
5
5
Vitreous Floaters
5
5
Myalgia
5
5
Renal Failure
5
5
Arthralgia
5
5
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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