TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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	1908	1908
2019	114	197
2020	13	13
2021	7	8
2022	8	8
2023	2	2

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	227	300
Incorrect, Inadequate or Imprecise Result or Readings	132	139
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	58	58
Leak/Splash	43	43
High Test Results	28	28
Computer Software Problem	18	18
Low Test Results	15	15
Fluid/Blood Leak	14	14
Calibration Problem	13	13
Noise, Audible	13	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
Non Reproducible Results	6	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
Fitting Problem	4	4
No Apparent Adverse Event	4	4
Mechanical Jam	4	6
Material Integrity Problem	3	3
Calibration Error	3	3
Detachment Of Device Component	2	2
Fire	2	2
Inaccurate Flow Rate	2	2
No Display/Image	2	2
Poor Quality Image	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
Communication or Transmission Problem	2	2
Computer Operating System Problem	2	2
Data Problem	2	2
Missing Test Results	1	1
Fail-Safe Did Not Operate	1	1
Appropriate Term/Code Not Available	1	1
Power Problem	1	1
Malposition of Device	1	1
Folded	1	1
Date/Time-Related Software Problem	1	1
Material Separation	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
Unable to Obtain Readings	1	2
Failure to Recalibrate	1	1
Difficult to Remove	1	1
Incorrect Measurement	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 Consequences Or Impact To Patient	29	29
No Clinical Signs, Symptoms or Conditions	18	19
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