TPLC - Total Product Life Cycle

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Device	culture media, antimicrobial susceptibility test, excluding mueller hinton agar
Regulation Description	Culture medium for antimicrobial susceptibility tests.
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 Result or Readings	483	483
False Positive Result	89	89
False Negative Result	5	5
Device Markings/Labelling Problem	4	4
Defective Device	4	4
Contamination of Device Ingredient or Reagent	3	3
Device Ingredient or Reagent Problem	2	2
Contamination	2	2
Output Problem	1	1
Incorrect Measurement	1	1
Device Contamination with Chemical or Other Material	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	590	590
No Consequences Or Impact To Patient	3	3
Drug Resistant Bacterial Infection	2	2
No Known Impact Or Consequence To Patient	1	1
Insufficient Information	1	1