TPLC - Total Product Life Cycle

• Device: assay, glycosylated hemoglobin
• Product Code: LCP
• Regulation Number: 864.7470
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT DIAGNOSTICS TECHNOLOGIES AS
	SUBSTANTIALLY EQUIVALENT	1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
	SUBSTANTIALLY EQUIVALENT	1
DRAWBRIDGE HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
EKF-DIAGNOSTIC GMBH
	SUBSTANTIALLY EQUIVALENT	1
IXENSOR CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
IXENSOR CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JANA CARE, INC
	SUBSTANTIALLY EQUIVALENT	1
SKYLA CORPORATION H.S.P.B.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	1909	1909
2019	114	197
2020	13	13
2021	7	8
2022	8	8
2023	24	24

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	621	621
Device Displays Incorrect Message	432	432
Device Operational Issue	359	359
Device Issue	296	296
Mechanical Problem	228	301
Incorrect, Inadequate or Imprecise Result or Readings	135	142
Increase in Pressure	94	94
Incorrect Or Inadequate Test Results	77	77
Pressure Problem	72	72
Decrease in Pressure	63	63
Use of Device Problem	59	59
High Test Results	45	45
Leak/Splash	43	43
Computer Software Problem	18	18
Low Test Results	17	17
Fluid/Blood Leak	14	14
Calibration Problem	13	13
Noise, Audible	13	13
Non Reproducible Results	12	13
Output Problem	12	12
High Readings	12	12
Failure to Align	9	9
Connection Problem	9	9
Break	9	9
Obstruction of Flow	8	8
Low Readings	8	8
Complete Blockage	7	7
Occlusion Within Device	7	7
Imprecision	7	7
Physical Property Issue	7	7
Device Maintenance Issue	6	6
Failure to Calibrate	6	6
No Pressure	6	6
Device Ingredient or Reagent Problem	5	5
Contamination of Device Ingredient or Reagent	5	5
Bent	5	5
Partial Blockage	4	4
Image Resolution Poor	4	4
Material Integrity Problem	4	4
Fitting Problem	4	4
No Apparent Adverse Event	4	4
Mechanical Jam	4	6
Calibration Error	3	3
Detachment Of Device Component	2	2
Fire	2	2
Inaccurate Flow Rate	2	2
No Display/Image	2	2
Incorrect Measurement	2	2
Poor Quality Image	2	2
Communication or Transmission Problem	2	2
Computer Operating System Problem	2	2
Smoking	2	2
Infusion or Flow Problem	2	2
Issue With Displayed Error Message	2	2
Material Deformation	2	2
Loss of Data	2	2
Data Problem	2	2
Missing Test Results	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Power Problem	1	1
Temperature Problem	1	1
Fail-Safe Did Not Operate	1	1
Delamination	1	1
Detachment of Device or Device Component	1	1
Device Contamination With Biological Material	1	1
Device Sensing Problem	1	1
Filtration Problem	1	1
Incorrect Error Code	1	1
Material Twisted/Bent	1	1
Operating System Becomes Nonfunctional	1	1
Malposition of Device	1	1
Folded	1	1
Date/Time-Related Software Problem	1	1
Material Separation	1	1
Unable to Obtain Readings	1	2
Failure to Recalibrate	1	1
Difficult to Remove	1	1
Loose or Intermittent Connection	1	1
Loss of Power	1	1
Failure to Power Up	1	1
Device Difficult to Setup or Prepare	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Air Leak	1	1
Device Alarm System	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	1987	2070
No Clinical Signs, Symptoms or Conditions	42	43
No Consequences Or Impact To Patient	29	29
No Information	13	13
Therapeutic Response, Decreased	2	2
Test Result	2	2
No Patient Involvement	1	1
Missing Value Reason	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Polymer Technology Systems	II	Dec-13-2019
2	Siemens Healthcare Diagnostics, Inc.	II	Apr-14-2022
3	Siemens Healthcare Diagnostics, Inc.	II	Jul-31-2020
4	Siemens Healthcare Diagnostics, Inc.	II	Jun-05-2020
5	Tosoh Bioscience Inc	III	Dec-13-2018
6	Tosoh Bioscience Inc	II	Sep-25-2018
7	Tosoh Bioscience Inc	II	Aug-11-2018
8	Tosoh Bioscience Inc	II	May-14-2018