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TPLC
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Device
fluorometer, for clinical use
Product Code
KHO
Regulation Number
862.2560
Device Class
1
Premarket Reviews
Manufacturer
Decision
RADIOMETER MEDICAL APS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
65
65
2015
30
30
2016
35
35
2017
149
149
2018
2123
2123
2019
440
496
2020
257
257
2021
213
213
2022
224
224
2023
260
260
2024
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
1147
1201
Device Displays Incorrect Message
879
879
Device Operates Differently Than Expected
633
633
Device Operational Issue
542
542
Incorrect, Inadequate or Imprecise Result or Readings
398
412
Device Issue
369
369
High Test Results
113
113
Incorrect Or Inadequate Test Results
84
84
Imprecision
74
74
Electrical /Electronic Property Problem
64
64
Failure to Align
63
63
Output Problem
59
59
Maintenance Does Not Comply To Manufacturers Recommendations
48
48
False Reading From Device Non-Compliance
48
48
High Readings
40
40
Obstruction of Flow
39
39
Low Test Results
32
32
Leak/Splash
29
29
Fluid/Blood Leak
24
24
Use of Device Problem
24
24
Low Readings
22
22
Computer Software Problem
22
24
Calibration Problem
20
20
Noise, Audible
20
20
Temperature Problem
19
19
Infusion or Flow Problem
15
15
Mechanical Jam
14
14
Display or Visual Feedback Problem
12
12
Bent
12
12
Improper or Incorrect Procedure or Method
12
12
Loose or Intermittent Connection
11
11
Device Sensing Problem
10
10
Complete Blockage
9
9
Patient Data Problem
8
8
Partial Blockage
8
8
Break
8
8
Material Twisted/Bent
8
8
Non Reproducible Results
8
8
Adverse Event Without Identified Device or Use Problem
7
7
Failure to Pump
7
7
Failure to Calibrate
7
7
No Display/Image
7
7
Suction Problem
7
7
Device Maintenance Issue
7
7
Human Factors Issue
6
6
Computer Operating System Problem
6
6
Nonstandard Device
6
6
No Flow
6
6
Decreased Sensitivity
6
6
Communication or Transmission Problem
6
6
Suction Failure
6
6
Contamination
6
6
Device Ingredient or Reagent Problem
6
6
False Positive Result
5
5
Priming Problem
5
5
Connection Problem
5
5
Electrical Power Problem
5
5
Intermittent Continuity
5
5
Incorrect Measurement
5
5
Physical Property Issue
5
5
Image Display Error/Artifact
5
5
Air/Gas in Device
4
4
Material Deformation
4
4
Electrical Shorting
3
3
Pressure Problem
3
3
Detachment of Device or Device Component
3
3
Naturally Worn
3
3
Appropriate Term/Code Not Available
3
3
Display Difficult to Read
3
3
Power Problem
3
3
Defective Component
3
3
Data Problem
3
3
Fracture
2
2
Failure to Deliver
2
2
Degraded
2
2
Component Missing
2
2
Deformation Due to Compressive Stress
2
2
Intermittent Communication Failure
2
2
Inaccurate Delivery
2
2
Malposition of Device
2
2
Unable to Obtain Readings
2
2
Disconnection
2
2
Volume Accuracy Problem
2
2
Aspiration Issue
2
2
Fitting Problem
2
2
Loss of Power
2
2
False Device Output
2
2
Positioning Failure
2
2
Failure to Power Up
2
2
Inadequate or Insufficient Training
2
2
Application Network Problem
1
1
Device Handling Problem
1
1
Air Leak
1
1
Operating System Version or Upgrade Problem
1
1
Detachment Of Device Component
1
1
Sticking
1
1
Device Contamination With Biological Material
1
1
Failure to Clean Adequately
1
1
Optical Problem
1
1
Chemical Spillage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
2938
2994
No Clinical Signs, Symptoms or Conditions
812
812
Misdiagnosis
46
46
No Information
45
45
No Consequences Or Impact To Patient
24
24
Insufficient Information
10
10
Test Result
3
3
Thrombus
2
2
Missing Value Reason
2
2
No Code Available
1
1
Electric Shock
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ortho-Clinical Diagnostics
II
May-06-2019
2
Ortho-Clinical Diagnostics
II
Jan-27-2012
3
PerkinElmer Health Sciences, Inc.
III
Oct-11-2018
4
PerkinElmer Life and Analytical Sciences, Wallac, OY
II
Jan-27-2017
5
PerkinElmer Life and Analytical Sciences, Wallac, OY
II
Feb-28-2012
6
Tecan US, Inc.
II
Jul-02-2015
7
Tecan US, Inc.
III
Jan-15-2015
8
Tosoh Bioscience Inc
II
Jun-23-2020
9
Tosoh Bioscience Inc
II
Feb-11-2020
10
Tosoh Bioscience Inc
II
Dec-14-2018
11
Tosoh Bioscience Inc
II
Dec-13-2018
12
Tosoh Bioscience Inc
II
Dec-13-2018
13
Tosoh Bioscience Inc
II
Dec-06-2018
14
Tosoh Bioscience Inc
II
Nov-28-2018
15
Tosoh Bioscience Inc
II
Nov-19-2018
16
Tosoh Bioscience Inc
II
Nov-16-2018
17
Tosoh Bioscience Inc
II
Nov-14-2018
18
Tosoh Bioscience Inc
II
Jan-31-2018
19
Tosoh Smd Inc
II
Jul-30-2013
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