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
NOVA BIOMEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	681	681
Wireless Communication Problem	358	358
Incorrect, Inadequate or Imprecise Result or Readings	338	338
Electrical /Electronic Property Problem	238	238
High Test Results	38	38
Appropriate Term/Code Not Available	38	38
Non Reproducible Results	34	34
Low Test Results	31	31
Communication or Transmission Problem	24	24
Low Readings	10	10
No Apparent Adverse Event	8	8
Battery Problem	7	7
Patient Data Problem	7	7
Failure to Sense	7	7
Material Integrity Problem	6	6
Insufficient Information	6	6
Problem with Software Installation	4	4
Failure to Power Up	4	4
Device Alarm System	4	4
Overheating of Device	3	3
Peeled/Delaminated	3	3
Material Twisted/Bent	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Unauthorized Access to Computer System	3	3
Inaccurate Information	3	3
Physical Resistance/Sticking	3	3
Failure to Obtain Sample	2	2
Image Display Error/Artifact	2	2
Labelling, Instructions for Use or Training Problem	1	1
Loose or Intermittent Connection	1	1
Incorrect Measurement	1	1
Moisture Damage	1	1
Component Incompatible	1	1
Display Difficult to Read	1	1
Display or Visual Feedback Problem	1	1
Unable to Obtain Readings	1	1
Device Damaged Prior to Use	1	1
Defective Component	1	1
Obstruction of Flow	1	1
Device Displays Incorrect Message	1	1
Therapeutic or Diagnostic Output Failure	1	1
Output Problem	1	1
Expiration Date Error	1	1
Device Markings/Labelling Problem	1	1
Environmental Compatibility Problem	1	1
Failure of Device to Self-Test	1	1
Erratic Results	1	1
Explosion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1519	1519
No Known Impact Or Consequence To Patient	82	82
No Consequences Or Impact To Patient	61	61
Insufficient Information	36	36
Hypoglycemia	30	30
Hyperglycemia	24	24
No Patient Involvement	16	16
Shaking/Tremors	7	7
Dizziness	4	4
Discomfort	3	3
Nausea	3	3
Fatigue	3	3
Dysphasia	2	2
Weakness	2	2
Loss of consciousness	2	2
Test Result	2	2
No Information	1	1
Irritability	1	1
Sweating	1	1
Anxiety	1	1
Distress	1	1
Confusion/ Disorientation	1	1
Lethargy	1	1
Chemical Exposure	1	1
Polydipsia	1	1
Burning Sensation	1	1
Complaint, Ill-Defined	1	1
Hypoesthesia	1	1
Diabetic Ketoacidosis	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Syncope	1	1
Endophthalmitis	1	1
Respiratory Distress Syndrome of Newborns	1	1
Therapeutic Effects, Unexpected	1	1
Visual Impairment	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