TPLC - Total Product Life Cycle

• 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