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
INSTRUMENTATION LABORATORY CO.
	SUBSTANTIALLY EQUIVALENT	1
MEDICA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NOVA BIOMEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
YSI INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	684	684
Incorrect, Inadequate or Imprecise Result or Readings	376	376
Wireless Communication Problem	366	366
Electrical /Electronic Property Problem	247	247
High Test Results	50	50
Low Test Results	40	40
Appropriate Term/Code Not Available	38	38
Non Reproducible Results	35	35
Communication or Transmission Problem	24	24
Erratic Results	18	18
Low Readings	10	10
No Apparent Adverse Event	8	8
Failure to Sense	7	7
Material Integrity Problem	7	7
Patient Data Problem	7	7
Battery Problem	7	7
Insufficient Information	6	6
Device Alarm System	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Problem with Software Installation	4	4
Failure to Power Up	4	4
Overheating of Device	3	3
Inaccurate Information	3	3
Unauthorized Access to Computer System	3	3
Material Twisted/Bent	3	3
Peeled/Delaminated	3	3
Physical Resistance/Sticking	3	3
Failure to Obtain Sample	2	2
Image Display Error/Artifact	2	2
Display or Visual Feedback Problem	2	2
Unable to Obtain Readings	1	1
Moisture Damage	1	1
Obstruction of Flow	1	1
Therapeutic or Diagnostic Output Failure	1	1
Expiration Date Error	1	1
Defective Component	1	1
Environmental Compatibility Problem	1	1
Device Markings/Labelling Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Incorrect Measurement	1	1
Explosion	1	1
Device Damaged Prior to Use	1	1
Display Difficult to Read	1	1
Failure of Device to Self-Test	1	1
Component Incompatible	1	1
Loose or Intermittent Connection	1	1
Device Displays Incorrect Message	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1608	1608
No Known Impact Or Consequence To Patient	82	82
No Consequences Or Impact To Patient	61	61
Hypoglycemia	39	39
Insufficient Information	36	36
Hyperglycemia	26	26
No Patient Involvement	16	16
Shaking/Tremors	7	7
Dizziness	5	5
Fatigue	4	4
Loss of consciousness	4	4
Nausea	3	3
Discomfort	3	3
Dysphasia	2	2
Test Result	2	2
Weakness	2	2
Headache	2	2
Distress	2	2
Syncope	1	1
Complaint, Ill-Defined	1	1
Sweating	1	1
Endophthalmitis	1	1
Diabetic Ketoacidosis	1	1
No Information	1	1
Chemical Exposure	1	1
Confusion/ Disorientation	1	1
Burning Sensation	1	1
Visual Impairment	1	1
Anxiety	1	1
Polydipsia	1	1
Hemorrhage/Bleeding	1	1
Respiratory Distress Syndrome of Newborns	1	1
Therapeutic Effects, Unexpected	1	1
Hypoesthesia	1	1
Irritability	1	1
Lethargy	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	Medline Industries Inc	II	Nov-22-2019
4	Ortho-Clinical Diagnostics	II	Aug-06-2019
5	Polymer Technology Systems, Inc.	II	May-23-2019
6	Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.	III	Sep-14-2022
7	Randox Laboratories Ltd.	II	Oct-31-2023
8	Siemens Healthcare Diagnostics Inc	II	Sep-15-2020