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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 994
Low test results 603
Contamination during use 408
High Readings 357
Leak 271
Incorrect or inadequate test results 264
Device displays error message 247
Other (for use when an appropriate device code cannot be identified) 235
High test results 187
Output issue 146
Syringe, defective 116
Sensor problems 92
Incorrect or inadequate result 75
Break 64
Device operates differently than expected 51
Component incompatible 49
Smoking 45
No Known Device Problem 39
Malfunction 28
Missing test results 25
Device alarm system issue 23
Unknown (for use when the device problem is not known) 19
Mechanical issue 19
Fire 16
Burn of device or device component 13
No Information 12
Device handling issue 11
Device Issue 10
Low readings 10
Computer software issue 10
Failure, intermittent 10
Failure to sense 10
No code available 9
Improper device output 8
Imprecision 8
Device clogged 8
Air leak 7
Electrical issue 7
Device inoperable 7
Overfill 7
Naturally worn 7
Improper or incorrect procedure or method 6
Use of Device Issue 5
Display misread 5
Incorrect display 5
Charred 5
Data Issue 5
Patient Data Issue 5
Installation-related problem 5
Electrical shorting 5
Aspiration issue 4
Device contamination with blood or blood product 4
Output below specifications 4
Defective component 4
Output above specifications 3
Repair 3
Device maintenance issue 3
Nonstandard device or device component 3
Shock, electrical 3
Use of Incorrect Control Settings 3
False positive result 3
Spark 3
Split 2
Defective item 2
Device ingredient or reagent issue 2
Issue with displayed error message 2
Dislodged or dislocated 2
Material integrity issue 2
Pressure issue 2
False reading from device non-compliance 2
Kinked 2
Disconnection 2
Circuit Failure 2
Detachment of device component 2
Bent 2
Loose or intermittent connection 2
Perivalvular leak 2
Sticking 2
Device stops intermittently 2
Spillage, accidental 1
Shelf life exceeded 1
Air eliminator, defective 1
Electro-static discharge 1
Fitting problem 1
Loss of power 1
Difficult to remove 1
Replace 1
No device output 1
Overheating of device or device component 1
Misapplication 1
Incorrect measurement 1
Normal 1
Device emits odor 1
Unintended collision 1
Unintended system motion 1
Blockage within device or device component 1
Delayed alarm 1
False alarm 1
Alarm, failure of warning 1
Aspiration, incomplete 1
Total Device Problems 4668

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