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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device counter, differential cell
Product CodeGKZ
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
ATHELAS INC.
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
HORIBA ABX SAS
  SUBSTANTIALLY EQUIVALENT 1
IMMUDEX APS
  SUBSTANTIALLY EQUIVALENT 1
NANOENTEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
PIXCELL MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS HEMATOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
S.D. SIGHT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIGHT DIAGNOSTICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYSMEX AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2017 229 229
2018 497 497
2019 908 908
2020 342 342
2021 391 391
2022 137 137

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 1609 1609
Fluid Leak 202 202
Low Test Results 159 159
Pressure Problem 106 106
High Test Results 83 83
Output Problem 69 69
Adverse Event Without Identified Device or Use Problem 57 57
Use of Device Problem 27 27
Leak/Splash 26 26
Smoking 24 24
Incorrect Or Inadequate Test Results 20 20
Thermal Decomposition of Device 14 14
Low Readings 10 10
Device Handling Problem 10 10
Contamination 9 9
Mechanical Problem 9 9
Patient Data Problem 8 8
Insufficient Information 6 6
Device Markings/Labelling Problem 6 6
Fire 6 6
Improper or Incorrect Procedure or Method 6 6
Incorrect Measurement 5 5
Overheating of Device 5 5
Charred 5 5
Unintended Electrical Shock 4 4
Missing Information 3 3
Electrical Shorting 3 3
Improper Device Output 3 3
Maintenance Does Not Comply To Manufacturers Recommendations 3 3
Computer Software Problem 3 3
Sparking 3 3
High Readings 2 2
Obstruction of Flow 2 2
Electrical /Electronic Property Problem 2 2
Temperature Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Sharp Edges 2 2
Device Fell 2 2
Appropriate Term/Code Not Available 2 2
Data Problem 2 2
Missing Test Results 1 1
Explosion 1 1
Intermittent Communication Failure 1 1
Priming Problem 1 1
Human-Device Interface Problem 1 1
Installation-Related Problem 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Device Sensing Problem 1 1
Unintended Movement 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Mechanical Jam 1 1
False Negative Result 1 1
Display Difficult to Read 1 1
Display or Visual Feedback Problem 1 1
Air Leak 1 1
Complete Blockage 1 1
Device Remains Activated 1 1
Difficult to Remove 1 1
Melted 1 1
Nonstandard Device 1 1
Device Maintenance Issue 1 1
Defective Component 1 1
Inadequate or Insufficient Training 1 1
Retraction Problem 1 1
Failure to Read Input Signal 1 1
Device Displays Incorrect Message 1 1
Application Program Problem 1 1
Blocked Connection 1 1
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1447 1447
No Clinical Signs, Symptoms or Conditions 557 557
No Known Impact Or Consequence To Patient 270 270
No Patient Involvement 135 135
Test Result 66 66
No Code Available 16 16
Not Applicable 9 9
Injury 6 6
Needle Stick/Puncture 6 6
Eye Injury 6 6
Misdiagnosis 3 3
Head Injury 2 2
Exposure to Body Fluids 2 2
Electric Shock 2 2
No Information 2 2
Insufficient Information 2 2
Cancer 1 1
Unspecified Blood or Lymphatic problem 1 1
Unspecified Eye / Vision Problem 1 1
Swelling/ Edema 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Fracture, Arm 1 1
Reaction 1 1
Death 1 1
Fall 1 1
Shock 1 1
Skin Irritation 1 1
Aspiration/Inhalation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Oct-22-2019
2 Abbott Laboratories II Mar-29-2019
3 Abbott Laboratories II Mar-09-2017
4 Beckman Coulter Inc. I May-23-2019
5 Beckman Coulter Inc. I Nov-20-2018
6 Beckman Coulter Inc. II Dec-13-2017
7 Beckman Coulter Inc. II Sep-07-2017
8 Beckman Coulter Inc. II Sep-01-2017
9 Beckman Coulter Inc. II May-24-2017
10 Beckman Coulter Inc. II Jan-11-2017
11 Beckman Coulter, Inc. II Nov-22-2019
12 Clinical Diagnostic Solutions, Inc. II Feb-05-2020
13 JAS Diagnostics Inc. II Jun-30-2017
14 SIGHT DIAGNOSTICS LTD II Jul-27-2022
15 SIGHT DIAGNOSTICS LTD II Apr-21-2022
16 SIGHT DIAGNOSTICS LTD II Sep-22-2021
17 Siemens Healthcare Diagnostics, Inc. II Apr-09-2021
18 Sysmex America Inc II Apr-14-2017
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