TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
AD ASTRA DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ATHELAS INC.
	SUBSTANTIALLY EQUIVALENT	1
BECKMAN COULTER
	SE - WITH LIMITATIONS	1
	SUBSTANTIALLY EQUIVALENT	2
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANOENTEK, INC.
	SUBSTANTIALLY EQUIVALENT	2
PIXCELL MEDICAL TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1
S.D. SIGHT DIAGNOSTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGHT DIAGNOSTICS LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYSMEX AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	1361	1361
Fluid/Blood Leak	200	200
Low Test Results	142	142
High Test Results	59	59
Leak/Splash	38	38
Use of Device Problem	30	30
Adverse Event Without Identified Device or Use Problem	27	27
Smoking	22	22
Device Markings/Labelling Problem	16	16
Low Readings	14	14
Output Problem	13	13
Thermal Decomposition of Device	12	12
Contamination	10	10
Improper or Incorrect Procedure or Method	10	10
Patient Data Problem	7	7
Unintended Electrical Shock	5	5
Sparking	5	5
Fire	4	4
Incorrect Measurement	4	4
Mechanical Problem	4	4
Missing Information	4	4
Wrong Label	3	3
Contamination of Device Ingredient or Reagent	3	3
Unintended Movement	3	3
Insufficient Information	3	3
High Readings	3	3
Obstruction of Flow	2	2
Electrical Shorting	2	2
Device Contamination with Chemical or Other Material	2	2
Overheating of Device	2	2
Failure to Read Input Signal	2	2
Computer Software Problem	2	2
Device Handling Problem	2	2
Device Fell	2	2
Temperature Problem	1	1
Non Reproducible Results	1	1
Intermittent Communication Failure	1	1
Priming Problem	1	1
Missing Test Results	1	1
Sharp Edges	1	1
Appropriate Term/Code Not Available	1	1
Data Problem	1	1
Break	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
False Negative Result	1	1
Retraction Problem	1	1
Device Remains Activated	1	1
Difficult to Remove	1	1
Installation-Related Problem	1	1
Material Integrity Problem	1	1
Mechanical Jam	1	1
Fail-Safe Problem	1	1
Blocked Connection	1	1
Contamination /Decontamination Problem	1	1
Defective Component	1	1
Arcing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	962	962
No Clinical Signs, Symptoms or Conditions	781	781
No Known Impact Or Consequence To Patient	125	125
No Patient Involvement	123	123
Test Result	10	10
Needle Stick/Puncture	6	6
Injury	5	5
No Code Available	5	5
Eye Injury	4	4
Exposure to Body Fluids	3	3
Misdiagnosis	3	3
No Information	2	2
Electric Shock	2	2
Unspecified Blood or Lymphatic problem	2	2
Muscle/Tendon Damage	2	2
Insufficient Information	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Swelling/ Edema	1	1
Unspecified Eye / Vision Problem	1	1
Cancer	1	1
Lymphoma	1	1
Chemical Exposure	1	1
Abdominal Pain	1	1
Fall	1	1
Fever	1	1
Head Injury	1	1
Pain	1	1
Shock	1	1
Fracture, Arm	1	1
Reaction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	II	Dec-21-2023
2	Abbott Laboratories	II	Oct-22-2019
3	Abbott Laboratories	II	Mar-29-2019
4	Beckman Coulter Inc.	I	May-23-2019
5	Beckman Coulter, Inc.	II	Nov-22-2019
6	Becton, Dickinson and Company, BD Biosciences	II	Nov-03-2022
7	Clinical Diagnostic Solutions, Inc.	II	Feb-05-2020
8	SIGHT DIAGNOSTICS LTD	II	Jul-27-2022
9	SIGHT DIAGNOSTICS LTD	II	Apr-21-2022
10	SIGHT DIAGNOSTICS LTD	II	Sep-22-2021
11	Siemens Healthcare Diagnostics, Inc.	II	Apr-09-2021