TPLC - Total Product Life Cycle

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Device	stains, microbiologic
Regulation Description	Dye and chemical solution stains.
Product Code	JTS
Regulation Number	864.1850
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	43	43
Device Contamination with Chemical or Other Material	35	35
Signal Artifact/Noise	21	21
False Positive Result	19	19
Device Markings/Labelling Problem	14	14
Precipitate in Device or Device Ingredient	13	13
Image Display Error/Artifact	6	6
Contamination /Decontamination Problem	5	5
Expiration Date Error	4	4
Clumping in Device or Device Ingredient	2	2
Defective Device	2	2
Leak/Splash	1	1
Off-Label Use	1	1
Therapeutic or Diagnostic Output Failure	1	1
Contamination	1	1
Moisture Damage	1	1
Missing Information	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	78	78
No Clinical Signs, Symptoms or Conditions	30	30
No Consequences Or Impact To Patient	12	12
Test Result	9	9
No Code Available	5	5
Therapeutic Effects, Unexpected	4	4
No Patient Involvement	2	2
Bacterial Infection	2	2
Fungus	1	1
Fungal Infection	1	1
Abrasion	1	1
Chemical Exposure	1	1
Discomfort	1	1