TPLC - Total Product Life Cycle

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Device	dna probe, nucleic acid amplification, chlamydia
Product Code	MKZ
Regulation Number	866.3120
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	7	7
Adverse Event Without Identified Device or Use Problem	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
False Positive Result	5	5
Break	4	4
Insufficient Information	4	4
Use of Device Problem	3	3
Appropriate Term/Code Not Available	2	2
Improper or Incorrect Procedure or Method	2	2
Incorrect Or Inadequate Test Results	2	2
Off-Label Use	2	2
Difficult to Remove	1	1
Detachment Of Device Component	1	1
False Reading From Device Non-Compliance	1	1
Fracture	1	1
Malposition of Device	1	1
Device Operates Differently Than Expected	1	1
Material Integrity Problem	1	1
Data Problem	1	1
Volume Accuracy Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	14	14
No Consequences Or Impact To Patient	6	6
Foreign Body In Patient	5	5
No Known Impact Or Consequence To Patient	3	3
Obstruction/Occlusion	2	2
Nasal Obstruction	2	2
Chemical Exposure	2	2
Sedation	2	2
Reaction	1	1
Numbness	1	1
Complaint, Ill-Defined	1	1
Toxicity	1	1
Hypersensitivity/Allergic reaction	1	1
Laceration(s)	1	1
Red Eye(s)	1	1
Swelling	1	1
Vomiting	1	1
Test Result	1	1
No Code Available	1	1
Insufficient Information	1	1