TPLC - Total Product Life Cycle

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Device	nucleic acid amplification assay system, group b streptococcus, direct specimen test
Definition	A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of group b streptococci from pre-partum and intra-partum women to establish colonization status.
Product Code	NJR
Regulation Number	866.3740
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	18	18
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Unintended Movement	1	1
Material Deformation	1	1
False Negative Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	16	16
Insufficient Information	4	4
Septic Shock	2	2
No Consequences Or Impact To Patient	1	1
Meningitis	1	1
No Known Impact Or Consequence To Patient	1	1
Convulsion/Seizure	1	1
Unspecified Respiratory Problem	1	1
Bacterial Infection	1	1
Feeding Problem	1	1
Fever	1	1
Pulmonary Dysfunction	1	1
Respiratory Distress Syndrome of Newborns	1	1
Sepsis	1	1