TPLC - Total Product Life Cycle

• Device: system, mass spectrometry, maldi tof, microorganism identification, cultured isolates
• Definition: A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
• Product Code: PEX
• Regulation Number: 866.3361
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BIOMERIEUX, INC.
	GRANTED	1
	SUBSTANTIALLY EQUIVALENT	1
BRUKER DALTONICS, INC
	SUBSTANTIALLY EQUIVALENT	2
BRUKER DALTONIK GMBH
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2015	23	23
2016	48	48
2017	94	94
2018	66	66
2019	107	107
2020	89	89
2021	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	284	284
Incorrect Or Inadequate Test Results	130	130
Grounding Malfunction	5	5
Protective Measures Problem	5	5
Device Operates Differently Than Expected	2	2
Output Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Data Problem	1	1
Patient Data Problem	1	1
Missing Test Results	1	1
Overheating of Device	1	1
Thermal Decomposition of Device	1	1
Charred	1	1
False Device Output	1	1
Sparking	1	1
Smoking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	203	203
No Consequences Or Impact To Patient	118	118
No Patient Involvement	96	96
Misdiagnosis	4	4
No Clinical Signs, Symptoms or Conditions	4	4
No Information	2	2
No Code Available	2	2
Abscess	2	2
Bacterial Infection	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomerieux Inc	II	Jan-04-2023