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
RADIOMETER MEDICALS APS
	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	362	365
Wireless Communication Problem	340	340
Electrical /Electronic Property Problem	165	165
High Test Results	80	80
Low Test Results	57	57
Erratic Results	49	49
Non Reproducible Results	40	40
Appropriate Term/Code Not Available	33	33
Communication or Transmission Problem	23	23
No Apparent Adverse Event	11	11
Material Integrity Problem	11	11
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
Problem with Software Installation	3	3
Material Twisted/Bent	3	3
Unauthorized Access to Computer System	3	3
Power Problem	3	3
Device Alarm System	3	3
Inaccurate Information	3	3
Unable to Obtain Readings	2	2
Image Display Error/Artifact	2	2
Display or Visual Feedback Problem	2	2
Physical Resistance/Sticking	2	2
Moisture Damage	1	1
High Readings	1	1
Patient Device Interaction Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Discolored	1	1
Failure to Power Up	1	1
Obstruction of Flow	1	1
Defective Device	1	1
Failure to Obtain Sample	1	1
Environmental Compatibility Problem	1	1
Defective Component	1	1
Display Difficult to Read	1	1
Labelling, Instructions for Use or Training Problem	1	1
Incorrect Measurement	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	1685	1688
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
Headache	1	1
Hemorrhage/Bleeding	1	1
Respiratory Distress Syndrome of Newborns	1	1
Irritability	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