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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device slide stainer, automated
Product CodeKPA
Regulation Number 864.3800
Device Class 1

MDR Year MDR Reports MDR Events
2014 16 16
2015 11 11
2016 31 31
2017 8 8
2018 13 13
2019 26 26
2020 436 436
2021 323 323
2022 161 161
2023 125 125
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 468 468
Mechanical Problem 322 322
Fluid/Blood Leak 256 256
Activation, Positioning or Separation Problem 87 87
Therapeutic or Diagnostic Output Failure 87 87
Leak/Splash 63 63
Break 44 44
Adverse Event Without Identified Device or Use Problem 20 20
Appropriate Term/Code Not Available 20 20
Air/Gas in Device 19 19
Fire 15 15
False Negative Result 10 10
Smoking 10 10
Incorrect Or Inadequate Test Results 10 10
Defective Device 9 9
Output Problem 9 9
Circuit Failure 9 9
Insufficient Information 9 9
Data Problem 9 9
Use of Device Problem 8 8
Gas/Air Leak 8 8
Sparking 8 8
Thermal Decomposition of Device 7 7
Off-Label Use 5 5
Device Emits Odor 5 5
Electrical Shorting 5 5
Detachment of Device or Device Component 4 4
Device Displays Incorrect Message 4 4
Calibration Problem 4 4
Failure to Align 4 4
Loose or Intermittent Connection 4 4
False Positive Result 4 4
Material Discolored 4 4
Crack 3 3
Electrical /Electronic Property Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Deliver 3 3
Inaccurate Delivery 3 3
Nonstandard Device 3 3
Device Ingredient or Reagent Problem 3 3
Device Sensing Problem 3 3
Temperature Problem 3 3
Unexpected Color 3 3
Intermittent Program or Algorithm Execution 2 2
Inaccurate Dispensing 2 2
Unable to Obtain Readings 2 2
Defective Component 2 2
Component Missing 2 2
Obstruction of Flow 2 2
Communication or Transmission Problem 2 2
Fracture 2 2
Melted 2 2
Device Alarm System 2 2
Complete Blockage 2 2
Computer Software Problem 2 2
Contamination 1 1
Intermittent Continuity 1 1
Corroded 1 1
Alarm Not Visible 1 1
Degraded 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Misconnection 1 1
Overheating of Device 1 1
Loss of Power 1 1
Insufficient Heating 1 1
Suction Problem 1 1
Failure to Pump 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Contamination /Decontamination Problem 1 1
Application Program Version or Upgrade Problem 1 1
High Test Results 1 1
Infusion or Flow Problem 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Program or Algorithm Execution Failure 1 1
Suction Failure 1 1
Misassembly During Maintenance/Repair 1 1
Patient Data Problem 1 1
Device Handling Problem 1 1
Unintended Electrical Shock 1 1
Intermittent Energy Output 1 1
Missing Value Reason 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 699 699
No Known Impact Or Consequence To Patient 364 364
No Consequences Or Impact To Patient 33 33
Insufficient Information 27 27
Fall 13 13
Injury 11 11
No Code Available 11 11
Tissue Damage 5 5
No Information 5 5
Cancer 4 4
Burn(s) 3 3
Pain 3 3
Bruise/Contusion 2 2
Test Result 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Limb Fracture 1 1
Discomfort 1 1
Reaction 1 1
Needle Stick/Puncture 1 1
No Patient Involvement 1 1
Respiratory Distress 1 1
Swelling 1 1
Head Injury 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Molecular II Aug-31-2010
2 Beckman Coulter Inc II Feb-25-2010
3 Beckman Coulter Inc. II Aug-20-2012
4 BioMerieux SA II Jun-12-2018
5 Biocare Medical, LLC II Apr-01-2021
6 Dako Denmark A/S II May-21-2020
7 Dako Denmark A/S II Dec-19-2012
8 Dako North America Inc. II Apr-29-2015
9 Dako North America Inc. II Mar-16-2015
10 Dako North America Inc. II Sep-26-2014
11 Hardy Diagnostics II Jun-09-2021
12 Hardy Diagnostics II Jul-08-2016
13 Leica Microsystems, Inc. II Oct-26-2018
14 Leica Microsystems, Inc. II Oct-03-2018
15 Roche Diagnostics Operations, Inc. II Oct-08-2020
16 Ventana Medical Systems Inc II Jul-12-2022
17 Ventana Medical Systems Inc II Apr-08-2022
18 Ventana Medical Systems Inc II Jun-05-2020
19 Ventana Medical Systems Inc II Aug-28-2013
20 Ventana Medical Systems Inc II Aug-06-2013
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