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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
Regulation Description Automated differential cell counter.
Product CodeGKZ
Regulation Number 864.5220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 27
BAYER
  SUBSTANTIALLY EQUIVALENT 5
BD
  SUBSTANTIALLY EQUIVALENT 12
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 27
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 3
NOVA
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SYSMEX
  SUBSTANTIALLY EQUIVALENT 20
UNIPATH
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Fluid leak 996
Low test results 619
Contamination during use 408
High Readings 357
Leak 271
Incorrect or inadequate test results 268
Device displays error message 248
Other (for use when an appropriate device code cannot be identified) 235
High test results 191
Output issue 156
Syringe, defective 116
Pressure issue 94
Sensor problems 92
Incorrect or inadequate result 75
Break 64
Device operates differently than expected 51
No Known Device Problem 50
Component incompatible 49
Smoking 46
Malfunction 28
Missing test results 26
Device alarm system issue 23
Mechanical issue 20
Unknown (for use when the device problem is not known) 19
Fire 16
Device handling issue 13
Burn of device or device component 13
No Information 12
Low readings 10
Device Issue 10
Computer software issue 10
Failure, intermittent 10
Failure to sense 10
Improper or incorrect procedure or method 9
No code available 9
Improper device output 8
Imprecision 8
Electrical issue 8
Device clogged 8
Air leak 7
Device inoperable 7
Naturally worn 7
Overfill 7
Electrical shorting 6
Installation-related problem 5
Data Issue 5
Patient Data Issue 5
Use of Device Issue 5
Charred 5
Display misread 5
Incorrect display 5
Output below specifications 4
Aspiration issue 4
Spark 4
Device contamination with blood or blood product 4
Defective component 4
Maintenance does not comply to manufacturers recommendations 3
Shock, electrical 3
Use of Incorrect Control Settings 3
False positive result 3
Output above specifications 3
Repair 3
Device maintenance issue 3
Nonstandard device or device component 3
Overheating of device or device component 3
Perivalvular leak 2
Incorrect measurement 2
Kinked 2
Loose or intermittent connection 2
Sticking 2
Device stops intermittently 2
False reading from device non-compliance 2
Disconnection 2
Circuit Failure 2
Detachment of device component 2
Bent 2
Issue with displayed error message 2
Positioning Issue 2
Dislodged or dislocated 2
Material integrity issue 2
Temperature issue 2
Split 2
Defective item 2
Device ingredient or reagent issue 2
Blocked connection 1
Electronic property issue 1
Expulsion 1
Foreign material present in device 1
Human-Device Interface Issue 1
Malposition of device 1
Application program issue 1
Air eliminator, defective 1
Failure to deliver 1
Electro-static discharge 1
Fitting problem 1
Dissatisfaction 1
Obstruction within device 1
Cut in material 1
Not Applicable 1
Protective measure issue 1
Total Device Problems 4826

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