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TPLC
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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
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