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TPLC
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show TPLC since
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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
3
ABBOTT POINT OF CARE, INC.
SUBSTANTIALLY EQUIVALENT
1
ALERE SAN DIEGO, INC.
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY CO
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
1
NOVA BIOMEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
3
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
2018
69
69
2019
116
116
2020
68
68
2021
48
48
2022
276
276
2023
1034
1034
Device Problems
MDRs with this Device Problem
Events in those MDRs
Computer Software Problem
661
661
Wireless Communication Problem
339
339
Electrical /Electronic Property Problem
220
220
Incorrect, Inadequate or Imprecise Result or Readings
212
212
Appropriate Term/Code Not Available
35
35
Low Test Results
32
32
High Test Results
24
24
Communication or Transmission Problem
23
23
Non Reproducible Results
20
20
Incorrect Or Inadequate Test Results
12
12
Low Readings
10
10
No Apparent Adverse Event
8
8
Insufficient Information
7
7
Battery Problem
7
7
Patient Data Problem
7
7
Failure to Sense
7
7
Peeled/Delaminated
4
4
Failure to Power Up
4
4
Device Alarm System
4
4
Overheating of Device
3
3
Unable to Obtain Readings
3
3
Defective Component
3
3
Inaccurate Information
3
3
Unauthorized Access to Computer System
3
3
Material Twisted/Bent
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Output Problem
3
3
Problem with Software Installation
2
2
Material Integrity Problem
2
2
Failure to Obtain Sample
2
2
Image Display Error/Artifact
2
2
Improper or Incorrect Procedure or Method
2
2
Device Damaged Prior to Use
1
1
Off-Label Use
1
1
Loss of Power
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Moisture Damage
1
1
Component Incompatible
1
1
Display or Visual Feedback Problem
1
1
Device Displays Incorrect Message
1
1
Expiration Date Error
1
1
Device Markings/Labelling Problem
1
1
Device Operates Differently Than Expected
1
1
Environmental Compatibility Problem
1
1
Failure of Device to Self-Test
1
1
Obstruction of Flow
1
1
High Readings
1
1
Therapeutic or Diagnostic Output Failure
1
1
Erratic Results
1
1
Device Handling Problem
1
1
Explosion
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1295
1295
No Known Impact Or Consequence To Patient
107
107
No Consequences Or Impact To Patient
75
75
Insufficient Information
36
36
No Patient Involvement
24
24
Hyperglycemia
23
23
Hypoglycemia
23
23
Shaking/Tremors
8
8
Dizziness
6
6
No Information
5
5
Sweating
4
4
Ambulation Difficulties
3
3
Confusion/ Disorientation
3
3
Discomfort
3
3
Weakness
3
3
Nausea
3
3
Fatigue
3
3
Headache
2
2
Loss of consciousness
2
2
Test Result
2
2
Lethargy
1
1
Chemical Exposure
1
1
Polydipsia
1
1
Complaint, Ill-Defined
1
1
Hypoesthesia
1
1
Numbness
1
1
Urinary Frequency
1
1
Anxiety
1
1
Distress
1
1
Hemorrhage/Bleeding
1
1
Fever
1
1
Abnormal Blood Gases
1
1
Syncope
1
1
Endophthalmitis
1
1
Fainting
1
1
Respiratory Distress Syndrome of Newborns
1
1
Seizures
1
1
Therapeutic Effects, Unexpected
1
1
Visual Impairment
1
1
Burning Sensation
1
1
Chills
1
1
Dysphasia
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alere San Diego, Inc.
II
Aug-06-2022
2
Medline Industries Inc
II
Nov-22-2019
3
Ortho-Clinical Diagnostics
II
Aug-06-2019
4
Polymer Technology Systems, Inc.
II
May-23-2019
5
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
III
Sep-14-2022
6
Siemens Healthcare Diagnostics Inc
II
Sep-15-2020
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