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TPLC
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Device
system, test, blood glucose, over the counter
Regulation Description
Glucose test system.
Product Code
NBW
Regulation Number
862.1345
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT
SUBSTANTIALLY EQUIVALENT
2
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
2
ACON LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ACON LABORATORIES, INC.
SUBSTANTIALLY EQUIVALENT
4
AGAMATRIX, INC.
SUBSTANTIALLY EQUIVALENT
2
ALL MEDICUS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
ANDON HEALTH CO.,LTD
SUBSTANTIALLY EQUIVALENT
5
APEX BIOTECHNOLOGY CORP.
SUBSTANTIALLY EQUIVALENT
2
APPLIED BIOMEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
ARKRAY, INC.
SUBSTANTIALLY EQUIVALENT
2
ASCENSIA DIABETES CARE
SUBSTANTIALLY EQUIVALENT
2
ASCENSIA DIABETES CARE HOLDINGS AG
SUBSTANTIALLY EQUIVALENT
2
BIOLAND
SUBSTANTIALLY EQUIVALENT
1
BIOLAND TECHNOLOGY LTD.
SUBSTANTIALLY EQUIVALENT
1
BIONIME CORPORATION
SUBSTANTIALLY EQUIVALENT
5
BIOTEST MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
ENTRA HEALTH SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
EPS BIO TECHNOLOGY CORP.
SUBSTANTIALLY EQUIVALENT
2
INTUITY MEDICAL, INC
SUBSTANTIALLY EQUIVALENT
1
I-SENS, INC.
SUBSTANTIALLY EQUIVALENT
8
NOVA
SUBSTANTIALLY EQUIVALENT
2
NOVA BIOMEDICAL CORP.
SUBSTANTIALLY EQUIVALENT
2
OK BIOTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
OSANG HEALTHCARE CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
ROCHE DIABETES CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
SD BIOSENSOR, INC.
SUBSTANTIALLY EQUIVALENT
2
TAIDOC TECHNOLOGY CORPORATION
SUBSTANTIALLY EQUIVALENT
5
TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
TRIVIDIA HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
TYSON BIORESEARCH, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2016
76532
76532
2017
37530
37530
2018
16902
16902
2019
14471
14471
2020
10702
10702
2021
1873
1873
Device Problems
MDRs with this Device Problem
Events in those MDRs
Failure to Power Up
39269
39269
Device Displays Incorrect Message
38693
38693
Incorrect, Inadequate or Imprecise Resultor Readings
13910
13910
Incorrect Or Inadequate Test Results
13486
13486
Loss of Power
7617
7617
High Test Results
7186
7186
Device Operates Differently Than Expected
5074
5074
Device Alarm System
3436
3436
Gauges/Meters
2663
2663
Appropriate Term/Code Not Available
2201
2201
Low Test Results
2174
2174
No Display/Image
1903
1903
Battery Problem
1855
1855
Low Battery
1833
1833
High Readings
1691
1691
Component Missing
1647
1647
Charging Problem
1250
1250
Adverse Event Without Identified Device or Use Problem
1094
1094
Device Operational Issue
1067
1067
Device Damaged Prior to Use
1045
1045
Insufficient Information
1043
1043
Test Strip
1008
1008
Missing Test Results
860
860
Display Difficult to Read
832
832
False Reading From Device Non-Compliance
783
783
Sticking
742
742
Housing
605
605
Output Problem
566
566
Device Inoperable
560
560
Image Resolution Poor
544
544
Battery
515
515
Display
495
495
Low Readings
426
426
Device Stops Intermittently
425
425
Cover
413
413
Switch, Push Button
397
397
Unable to Obtain Readings
379
379
Inappropriate Audible Prompt/Feedback
370
370
Electrical /Electronic Property Problem
364
364
No Device Output
363
363
Device Handling Problem
349
349
Image Display Error/Artifact
346
346
Display or Visual Feedback Problem
342
342
Crack
340
340
Failure to Charge
335
335
Use of Incorrect Control Settings
326
326
Poor Quality Image
305
305
Failure to Calibrate
288
288
Incorrect Software Programming Calculations
276
276
Defective Component
270
270
Bent
251
251
Off-Label Use
242
242
Application Program Problem: Dose Calculation Error
239
239
Failure to Obtain Sample
209
209
Break
204
204
Material Discolored
199
199
Data Problem
176
176
Material Integrity Problem
171
171
Physical Property Issue
155
155
Labelling, Instructions for Use or Training Problem
154
154
Device Ingredient or Reagent Problem
130
130
Failure to Back-Up
128
128
Packaging Problem
123
123
Improper or Incorrect Procedure or Method
110
110
Premature Discharge of Battery
108
108
Device Markings/Labelling Problem
107
107
Inadequate Instructions for Healthcare Professional
101
101
Device Difficult to Setup or Prepare
101
101
Defective Device
96
96
Therapeutic or Diagnostic Output Failure
93
93
Improper Device Output
89
89
Reset Problem
88
88
Unsealed Device Packaging
86
86
Power Problem
80
80
Label
80
80
Incomplete or Missing Packaging
78
78
Failure to Shut Off
74
74
Port
73
73
Erratic or Intermittent Display
68
68
Incorrect Measurement
68
68
Indicator
61
61
Screen
58
58
Device Subassembly
56
56
Inappropriate or Unexpected Reset
54
54
Cable, Electrical
49
49
Memory/Storage
48
48
Melted
48
48
Loss of Data
48
48
Application Program Problem
47
47
Unit
45
45
Product Quality Problem
42
42
Computer Software Problem
41
41
Computer Operating System Problem
41
41
Material Opacification
29
29
Cut In Material
29
29
Peeled/Delaminated
29
29
Incorrect Device Or Component Shipped
28
28
Nonstandard Device
28
28
Adapter (Adaptor)
26
26
Device Packaging Compromised
26
26
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
79760
79760
No Consequences Or Impact To Patient
63373
63373
Hyperglycemia
3095
3096
Hypoglycemia
2773
2774
Shaking/Tremors
2373
2374
Sweating
2082
2082
Dizziness
2010
2011
No Clinical Signs, Symptoms or Conditions
1862
1862
Loss of consciousness
811
811
Weakness
781
781
Blurred Vision
742
742
Fatigue
740
740
Headache
733
733
Confusion/ Disorientation
717
718
Polydipsia
505
506
No Code Available
456
456
Urinary Frequency
438
438
Nausea
437
437
Fainting
408
408
Lethargy
339
339
No Information
288
288
Dysphasia
230
230
Syncope
218
218
Vomiting
202
202
Anxiety
194
194
Seizures
169
169
Diabetic Ketoacidosis
150
150
Malaise
123
123
Tachycardia
117
117
Alteration In Body Temperature
106
107
No Patient Involvement
102
102
Diaphoresis
84
84
Coma
79
79
Palpitations
76
76
Fall
76
76
Dyspnea
73
73
Visual Impairment
73
73
Complaint, Ill-Defined
69
69
Dehydration
69
69
Numbness
69
69
Ambulation Difficulties
69
69
Insufficient Information
68
68
Chills
59
59
Cognitive Changes
58
58
Pain
57
57
Vertigo
56
56
Chest Pain
51
51
Abdominal Pain
48
48
Irritability
45
45
Tingling
39
39
Patient Problem/Medical Problem
35
36
High Blood Pressure/ Hypertension
34
34
Hot Flashes/Flushes
31
31
Collapse
26
26
Fever
23
23
Syncope/Fainting
23
23
Diarrhea
22
22
Paresis
21
21
Pallor
21
21
Memory Loss/Impairment
19
19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Extreme Exhaustion
19
19
Loss of Vision
18
18
Swelling
18
18
Emotional Changes
17
17
Muscle Weakness
16
16
Cramp(s)
16
16
Shock, Insulin
16
16
Presyncope
15
15
Visual Disturbances
15
15
Convulsion/Seizure
15
15
Overdose
14
14
Death
14
14
Not Applicable
13
13
Sleep Dysfunction
13
13
Missing Value Reason
12
12
Unspecified Infection
12
12
Itching Sensation
11
11
Twitching
10
10
Abdominal Cramps
9
9
Neuropathy
8
8
Burning Sensation
8
8
Incontinence
8
8
Test Result
8
8
Chest Tightness/Pressure
8
8
Injury
8
8
Alteration in Body Temperature
8
8
Distress
7
7
Blood Loss
7
7
Weight Changes
7
7
Bone Fracture(s)
7
7
Respiratory Distress
7
7
Paralysis
7
7
Pneumonia
7
7
Tinnitus
7
7
Hypothermia
7
7
Low Blood Pressure/ Hypotension
6
6
Urinary Tract Infection
6
6
Head Injury
6
6
Eye Injury
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Diabetes Care, Inc.
II
Feb-28-2020
2
Cambridge Sensors Limited
II
Aug-22-2019
3
LABSTYLE INNOVATIONS
II
Oct-31-2019
4
Livongo Health
II
Apr-29-2016
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
Feb-05-2020
9
Roche Diabetes Care, Inc.
II
Dec-30-2019
10
Roche Diabetes Care, Inc.
II
Sep-30-2019
11
Trividia Health
II
Sep-23-2016
12
Trividia Health, Inc.
II
Jun-01-2020
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