TPLC - Total Product Life Cycle

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Device	mass spectrometry, maldi tof, microorganism identification, cultured isolates
Definition	The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.
Product Code	QBN
Regulation Number	866.3378
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	291	291
Incorrect Measurement	101	101
Adverse Event Without Identified Device or Use Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Electro-Static Discharge	1	1
Failure to Calibrate	1	1
Optical Obstruction	1	1
Unable to Obtain Readings	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	324	324
No Known Impact Or Consequence To Patient	49	49
No Consequences Or Impact To Patient	11	11
No Patient Involvement	11	11
Insufficient Information	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Misdiagnosis	1	1