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	44	44
Device Contamination with Chemical or Other Material	35	35
Device Markings/Labelling Problem	23	23
Signal Artifact/Noise	21	21
False Positive Result	19	19
Precipitate in Device or Device Ingredient	13	13
Image Display Error/Artifact	6	6
Contamination /Decontamination Problem	5	5
Expiration Date Error	4	4
Defective Device	2	2
Clumping in Device or Device Ingredient	2	2
Off-Label Use	1	1
Missing Information	1	1
Moisture Damage	1	1
Leak/Splash	1	1
Contamination	1	1
Improper or Incorrect Procedure or Method	1	1
Therapeutic or Diagnostic Output Failure	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	40	40
No Consequences Or Impact To Patient	12	12
Test Result	9	9
No Code Available	5	5
Therapeutic Effects, Unexpected	4	4
Bacterial Infection	2	2
No Patient Involvement	2	2
Abrasion	1	1
Fungus	1	1
Chemical Exposure	1	1
Discomfort	1	1
Fungal Infection	1	1