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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
2019 26 26
2020 436 436
2021 323 323
2022 161 161
2023 125 125
2024 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 459 459
Mechanical Problem 321 321
Fluid/Blood Leak 249 249
Activation, Positioning or Separation Problem 87 87
Therapeutic or Diagnostic Output Failure 86 86
Break 82 82
Structural Problem 70 70
Leak/Splash 61 61
Air/Gas in Device 19 19
Appropriate Term/Code Not Available 17 17
Fire 12 12
Output Problem 10 10
False Negative Result 9 9
Circuit Failure 9 9
Defective Device 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Gas/Air Leak 8 8
Smoking 8 8
Thermal Decomposition of Device 7 7
Sparking 7 7
Use of Device Problem 6 6
Electrical Shorting 5 5
Off-Label Use 5 5
Detachment of Device or Device Component 4 4
Device Emits Odor 4 4
Loose or Intermittent Connection 4 4
Material Discolored 4 4
Device Sensing Problem 3 3
Unexpected Color 3 3
Improper or Incorrect Procedure or Method 3 3
Electrical /Electronic Property Problem 3 3
Crack 3 3
Temperature Problem 3 3
Device Ingredient or Reagent Problem 3 3
Insufficient Information 3 3
Contamination /Decontamination Problem 2 2
Device Alarm System 2 2
Communication or Transmission Problem 2 2
Obstruction of Flow 2 2
Melted 2 2
Complete Blockage 2 2
Intermittent Program or Algorithm Execution 2 2
No Apparent Adverse Event 2 2
Fracture 2 2
Corroded 1 1
Loss of Power 1 1
Device Displays Incorrect Message 1 1
False Positive Result 1 1
Display or Visual Feedback Problem 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 740 740
No Known Impact Or Consequence To Patient 325 325
Insufficient Information 27 27
No Consequences Or Impact To Patient 26 26
Fall 10 10
Injury 5 5
Pain 2 2
Unspecified Tissue Injury 2 2
Bruise/Contusion 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Respiratory Distress 1 1
Head Injury 1 1
Burn(s) 1 1
Swelling 1 1
Discomfort 1 1
Laceration(s) 1 1
Limb Fracture 1 1
Swelling/ Edema 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agilent Technologies II May-29-2024
2 Biocare Medical, LLC II Apr-01-2021
3 Dako Denmark A/S II May-21-2020
4 Hardy Diagnostics II Jun-09-2021
5 Roche Diagnostics Operations, Inc. II Oct-08-2020
6 Ventana Medical Systems Inc II Jul-12-2022
7 Ventana Medical Systems Inc II Apr-08-2022
8 Ventana Medical Systems Inc II Jun-05-2020
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