TPLC - Total Product Life Cycle

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Device	culture media, antimicrobial susceptibility test, excluding mueller hinton agar
Product Code	JSO
Regulation Number	866.1700
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings	46	46
Incorrect Or Inadequate Test Results	25	25
False Positive Result	21	21
False Negative Result	6	6
Defective Device	3	3
Contamination of Device Ingredient or Reagent	2	2
Contamination	2	2
Material Discolored	1	1
Nonstandard Device	1	1
Device Markings/Labelling Problem	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	42	42
No Clinical Signs, Symptoms or Conditions	25	25
No Consequences Or Impact To Patient	22	22
No Patient Involvement	11	11
Misdiagnosis	4	4
Drug Resistant Bacterial Infection	1	1
Insufficient Information	1	1