TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT POINT OF CARE, INC.
	SUBSTANTIALLY EQUIVALENT	4
1. K183678 i-STAT CHEM8+ cartridge with the i-STAT 1 System
2. K210958 i-STAT CHEM8+ cartridge with the i-STAT 1 System
3. K223710 i-STAT CG8+ cartridge with the i-STAT 1 System
4. K223755 i-STAT G cartridge with the i-STAT 1 System
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	656	656
Incorrect, Inadequate or Imprecise Result or Readings	365	368
Wireless Communication Problem	339	339
Electrical /Electronic Property Problem	205	205
High Test Results	80	80
Low Test Results	60	60
Erratic Results	49	49
Non Reproducible Results	38	38
Appropriate Term/Code Not Available	34	34
Communication or Transmission Problem	23	23
No Apparent Adverse Event	10	10
Material Integrity Problem	10	10
Low Readings	9	9
Failure to Sense	7	7
Patient Data Problem	7	7
Battery Problem	7	7
Insufficient Information	6	6
Adverse Event Without Identified Device or Use Problem	4	4
Failure to Power Up	4	4
Problem with Software Installation	3	3
Material Twisted/Bent	3	3
Unauthorized Access to Computer System	3	3
Device Alarm System	3	3
Inaccurate Information	3	3
Display or Visual Feedback Problem	2	2
Physical Resistance/Sticking	2	2
Moisture Damage	1	1
High Readings	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unable to Obtain Readings	1	1
Defective Device	1	1
Obstruction of Flow	1	1
Failure to Obtain Sample	1	1
Expiration Date Error	1	1
Environmental Compatibility Problem	1	1
Defective Component	1	1
Device Markings/Labelling Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Incorrect Measurement	1	1
Display Difficult to Read	1	1
Failure of Device to Self-Test	1	1
Component Incompatible	1	1
Overheating of Device	1	1
Improper or Incorrect Procedure or Method	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1675	1678
Hypoglycemia	48	48
Insufficient Information	37	37
Hyperglycemia	27	27
No Consequences Or Impact To Patient	26	26
No Known Impact Or Consequence To Patient	22	22
Dizziness	5	5
No Patient Involvement	5	5
Shaking/Tremors	4	4
Loss of consciousness	4	4
Fatigue	3	3
Discomfort	3	3
Dysphasia	2	2
Test Result	2	2
Stroke/CVA	1	1
Complaint, Ill-Defined	1	1
Nausea	1	1
Diabetic Ketoacidosis	1	1
No Information	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
Therapeutic Effects, Unexpected	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
7	Siemens Healthcare Diagnostics Inc	II	Sep-15-2020