Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
Back to Search Results
Device
glucose oxidase, glucose
Product Code
CGA
Regulation Number
862.1345
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT POINT OF CARE INC.
SUBSTANTIALLY EQUIVALENT
1
ABBOTT POINT OF CARE, INC.
SUBSTANTIALLY EQUIVALENT
2
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
2
ORTHO CLINICAL DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
ORTHO-CLINICAL DIAGNOSTICS, INC.
SUBSTANTIALLY EQUIVALENT
1
POLYMER TECHNOLOGY SYSTEMS, INC. D/B/A PTS DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT - KIT
1
MDR Year
MDR Reports
MDR Events
2017
92
92
2018
69
69
2019
116
116
2020
68
68
2021
49
49
2022
675
675
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
510
510
Electrical /Electronic Property Problem
178
178
Communication or Transmission Problem
125
125
Incorrect, Inadequate or Imprecise Resultor Readings
61
61
Low Test Results
36
36
High Test Results
26
26
High Readings
23
23
Appropriate Term/Code Not Available
20
20
Incorrect Or Inadequate Test Results
19
19
No Apparent Adverse Event
12
12
Low Readings
11
11
Failure to Sense
7
7
Patient Data Problem
7
7
Adverse Event Without Identified Device or Use Problem
5
5
Failure to Power Up
5
5
Peeled/Delaminated
4
4
Device Displays Incorrect Message
4
4
Output Problem
4
4
Non Reproducible Results
4
4
Insufficient Information
3
3
Device Operates Differently Than Expected
3
3
Material Twisted/Bent
3
3
Defective Component
3
3
Overheating of Device
3
3
Unable to Obtain Readings
3
3
Loss of Power
2
2
Device Alarm System
2
2
Image Display Error/Artifact
2
2
Image Resolution Poor
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Failure to Obtain Sample
2
2
Problem with Software Installation
2
2
Device Markings/Labelling Problem
1
1
Device Operational Issue
1
1
Failure of Device to Self-Test
1
1
Human Factors Issue
1
1
Erratic Results
1
1
Device Handling Problem
1
1
Wireless Communication Problem
1
1
Explosion
1
1
Physical Resistance/Sticking
1
1
Defective Device
1
1
Patient-Device Incompatibility
1
1
Expiration Date Error
1
1
Device Damaged Prior to Use
1
1
Sticking
1
1
Invalid Sensing
1
1
Component Missing
1
1
Difficult to Insert
1
1
Loose or Intermittent Connection
1
1
Incorrect Measurement
1
1
Component Incompatible
1
1
Material Discolored
1
1
Display or Visual Feedback Problem
1
1
Material Fragmentation
1
1
Off-Label Use
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
547
547
Insufficient Information
176
176
No Known Impact Or Consequence To Patient
165
165
No Consequences Or Impact To Patient
78
78
No Patient Involvement
32
32
Hypoglycemia
17
17
Hyperglycemia
14
14
No Information
10
10
Shaking/Tremors
8
8
Sweating
5
5
Dizziness
4
4
Weakness
3
3
Ambulation Difficulties
3
3
Confusion/ Disorientation
3
3
Nausea
3
3
Headache
3
3
Test Result
3
3
No Code Available
3
3
Polydipsia
2
2
Fatigue
2
2
Skin Irritation
2
2
Loss of consciousness
2
2
Anxiety
2
2
Discomfort
1
1
Complaint, Ill-Defined
1
1
Hypoesthesia
1
1
Numbness
1
1
Burning Sensation
1
1
Chills
1
1
Dysphasia
1
1
Urinary Frequency
1
1
Lethargy
1
1
Chemical Exposure
1
1
Tachycardia
1
1
Therapeutic Effects, Unexpected
1
1
Visual Impairment
1
1
Renal Failure
1
1
Respiratory Distress Syndrome of Newborns
1
1
Seizures
1
1
Fever
1
1
Hemorrhage/Bleeding
1
1
Abnormal Blood Gases
1
1
Syncope
1
1
Endophthalmitis
1
1
Fainting
1
1
Device Embedded In Tissue or Plaque
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Medline Industries Inc
II
Nov-22-2019
2
Ortho-Clinical Diagnostics
II
Aug-06-2019
3
Polymer Technology Systems, Inc.
II
May-23-2019
4
Siemens Healthcare Diagnostics Inc
II
Sep-15-2020
-
-