TPLC - Total Product Life Cycle

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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
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	371	371
Incorrect, Inadequate or Imprecise Result or Readings	361	361
Electrical /Electronic Property Problem	191	191
High Test Results	80	80
Low Test Results	52	52
Erratic Results	49	49
Appropriate Term/Code Not Available	37	37
Non Reproducible Results	35	35
Communication or Transmission Problem	24	24
No Apparent Adverse Event	9	9
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
Adverse Event Without Identified Device or Use Problem	4	4
Failure to Power Up	4	4
Unauthorized Access to Computer System	3	3
Material Twisted/Bent	3	3
Inaccurate Information	3	3
Device Alarm System	3	3
Physical Resistance/Sticking	2	2
Display or Visual Feedback Problem	2	2
Therapeutic or Diagnostic Output Failure	1	1
Output Problem	1	1
Data Problem	1	1
Display Difficult to Read	1	1
Labelling, Instructions for Use or Training Problem	1	1
Incorrect Measurement	1	1
Moisture Damage	1	1
Overheating of Device	1	1
Unable to Obtain Readings	1	1
Component Incompatible	1	1
Obstruction of Flow	1	1
High Readings	1	1
Defective Component	1	1
Expiration Date Error	1	1
Failure to Obtain Sample	1	1
Improper or Incorrect Procedure or Method	1	1
Device Markings/Labelling Problem	1	1
Environmental Compatibility Problem	1	1
Failure of Device to Self-Test	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1705	1705
Hypoglycemia	47	47
Insufficient Information	37	37
Hyperglycemia	27	27
No Consequences Or Impact To Patient	26	26
No Known Impact Or Consequence To Patient	22	22
No Patient Involvement	5	5
Dizziness	5	5
Loss of consciousness	4	4
Shaking/Tremors	4	4
Discomfort	3	3
Fatigue	3	3
Diabetic Ketoacidosis	2	2
Test Result	2	2
Dysphasia	2	2
Distress	1	1
Complaint, Ill-Defined	1	1
Irritability	1	1
No Information	1	1
Convulsion/Seizure	1	1
Nausea	1	1
Respiratory Distress Syndrome of Newborns	1	1
Therapeutic Effects, Unexpected	1	1
Burning Sensation	1	1
Stroke/CVA	1	1
Headache	1	1
Hemorrhage/Bleeding	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	Mckesson Medical-Surgical Inc. Corporate Office	II	May-27-2025
4	Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.	III	Sep-14-2022
5	Randox Laboratories Ltd.	II	Oct-31-2023
6	Siemens Healthcare Diagnostics Inc	II	Sep-15-2020