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	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