TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT POINT OF CARE, INC.
	SUBSTANTIALLY EQUIVALENT	3
ALERE SAN DIEGO, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSTRUMENTATION LABORATORY CO
	SUBSTANTIALLY EQUIVALENT	1
MEDICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NOVA BIOMEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
YSI, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	656	656
Incorrect, Inadequate or Imprecise Result or Readings	358	361
Wireless Communication Problem	339	339
Electrical /Electronic Property Problem	162	162
High Test Results	79	79
Low Test Results	56	56
Erratic Results	49	49
Non Reproducible Results	39	39
Appropriate Term/Code Not Available	33	33
Communication or Transmission Problem	23	23
Material Integrity Problem	11	11
No Apparent Adverse Event	10	10
Failure to Sense	7	7
Patient Data Problem	7	7
Battery Problem	7	7
Insufficient Information	6	6
Low Readings	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Inaccurate Information	3	3
Unauthorized Access to Computer System	3	3
Material Twisted/Bent	3	3
Problem with Software Installation	3	3
Device Alarm System	3	3
Display or Visual Feedback Problem	2	2
Physical Resistance/Sticking	2	2
Unable to Obtain Readings	1	1
High Readings	1	1
Failure to Power Up	1	1
Obstruction of Flow	1	1
Moisture Damage	1	1
Therapeutic or Diagnostic Output Failure	1	1
Environmental Compatibility Problem	1	1
Defective Device	1	1
Failure to Obtain Sample	1	1
Labelling, Instructions for Use or Training Problem	1	1
Incorrect Measurement	1	1
Defective Component	1	1
Display Difficult to Read	1	1
Failure of Device to Self-Test	1	1
Component Incompatible	1	1
Output Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1668	1671
Hypoglycemia	46	46
Insufficient Information	36	36
Hyperglycemia	27	27
Dizziness	5	5
Shaking/Tremors	4	4
Loss of consciousness	4	4
Fatigue	3	3
Discomfort	3	3
Dysphasia	2	2
Stroke/CVA	1	1
Nausea	1	1
Diabetic Ketoacidosis	1	1
Burning Sensation	1	1
Hypothermia	1	1
Convulsion/Seizure	1	1
Hemorrhage/Bleeding	1	1
Respiratory Distress Syndrome of Newborns	1	1
Irritability	1	1
Headache	1	1
Distress	1	1
Decreased Appetite	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	HemoCue AB	II	Jul-02-2025
4	Mckesson Medical-Surgical Inc. Corporate Office	II	May-27-2025
5	Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.	III	Sep-14-2022
6	Randox Laboratories Ltd.	II	Oct-31-2023