TPLC - Total Product Life Cycle

show TPLC since

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
1. K223179 Cholestech LDX ™ System
INSTRUMENTATION LABORATORY CO
	SUBSTANTIALLY EQUIVALENT	1
MEDICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NOVA BIOMEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
YSI INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	689	689
Wireless Communication Problem	369	369
Incorrect, Inadequate or Imprecise Result or Readings	360	360
Electrical /Electronic Property Problem	188	188
High Test Results	86	86
Erratic Results	56	56
Low Test Results	52	52
Appropriate Term/Code Not Available	37	37
Non Reproducible Results	32	32
Communication or Transmission Problem	24	24
No Apparent Adverse Event	8	8
Low Readings	8	8
Material Integrity Problem	8	8
Battery Problem	7	7
Patient Data Problem	7	7
Failure to Sense	7	7
Insufficient Information	6	6
Problem with Software Installation	4	4
Failure to Power Up	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Material Twisted/Bent	3	3
Unauthorized Access to Computer System	3	3
Device Alarm System	3	3
Inaccurate Information	3	3
Display or Visual Feedback Problem	2	2
Physical Resistance/Sticking	2	2
Expiration Date Error	1	1
Failure to Obtain Sample	1	1
Therapeutic or Diagnostic Output Failure	1	1
Defective Component	1	1
Moisture Damage	1	1
Unable to Obtain Readings	1	1
Obstruction of Flow	1	1
Environmental Compatibility Problem	1	1
Data Problem	1	1
Device Markings/Labelling Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Incorrect Measurement	1	1
Display Difficult to Read	1	1
Failure of Device to Self-Test	1	1
Component Incompatible	1	1
Overheating of Device	1	1
Improper or Incorrect Procedure or Method	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1709	1709
Hypoglycemia	47	47
Insufficient Information	37	37
Hyperglycemia	28	28
No Consequences Or Impact To Patient	26	26
No Known Impact Or Consequence To Patient	22	22
Dizziness	5	5
No Patient Involvement	5	5
Shaking/Tremors	4	4
Loss of consciousness	4	4
Fatigue	3	3
Discomfort	3	3
Dysphasia	2	2
Diabetic Ketoacidosis	2	2
Test Result	2	2
Syncope/Fainting	1	1
Stroke/CVA	1	1
Complaint, Ill-Defined	1	1
Nausea	1	1
No Information	1	1
Burning Sensation	1	1
Convulsion/Seizure	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Respiratory Distress Syndrome of Newborns	1	1
Therapeutic Effects, Unexpected	1	1
Irritability	1	1
Distress	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Alere San Diego, Inc.	II	Apr-30-2024
2	Alere San Diego, Inc.	II	Aug-06-2022
3	Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.	III	Sep-14-2022
4	Randox Laboratories Ltd.	II	Oct-31-2023
5	Siemens Healthcare Diagnostics Inc	II	Sep-15-2020