TPLC - Total Product Life Cycle

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Device	gram-positive bacteria and their resistance markers
Regulation Description	Multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Definition	A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Product Code	PAM
Regulation Number	866.3365
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	468	468
False Negative Result	60	60
No Apparent Adverse Event	15	15
Volume Accuracy Problem	1	1
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	461	461
Insufficient Information	81	81
Unspecified Infection	1	1
Death	1	1
Sepsis	1	1
Fever	1	1
Heart Failure/Congestive Heart Failure	1	1
Renal Failure	1	1
Phlebitis	1	1
Respiratory Failure	1	1