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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, test, automated, antimicrobial susceptibility, short incubation
Regulation Description Fully automated short-term incubation cycle antimicrobial susceptibility system.
Product CodeLON
Regulation Number 866.1645
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON & COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON, DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 2
BECTON, DICKINSON, AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BECTON,DICKINSON AND COMPANY
  SUBSTANTIALLY EQUIVALENT 1
BIOMERIEUX, INC
  SUBSTANTIALLY EQUIVALENT 10
BIOMERIEUX, INC.
  SUBSTANTIALLY EQUIVALENT 16

MDR Year MDR Reports MDR Events
2017 197 197
2018 512 512
2019 315 315
2020 218 218
2021 232 232

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 976 976
Incorrect Or Inadequate Test Results 193 193
False Positive Result 180 180
Mechanical Problem 21 21
Computer Software Problem 19 19
False Negative Result 14 14
Missing Test Results 11 11
Use of Device Problem 10 10
Improper or Incorrect Procedure or Method 10 10
Contamination of Device Ingredient or Reagent 8 8
Incorrect Measurement 7 7
Output Problem 6 6
Communication or Transmission Problem 5 5
Unable to Obtain Readings 3 3
Data Back-Up Problem 3 3
Device Markings/Labelling Problem 3 3
Failure to Back-Up 3 3
Electrical /Electronic Property Problem 3 3
Device Damaged Prior to Use 3 3
Smoking 3 3
No Device Output 2 2
Contamination 2 2
Loss of Data 2 2
Expiration Date Error 2 2
Insufficient Information 2 2
Patient Data Problem 2 2
Data Problem 1 1
Failure to Obtain Sample 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Device Operational Issue 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Packaging Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Program or Algorithm Execution Failure 1 1
Inaccurate Information 1 1
Cross Reactivity 1 1
Fire 1 1
Leak/Splash 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 731 731
No Consequences Or Impact To Patient 380 380
No Clinical Signs, Symptoms or Conditions 206 206
No Patient Involvement 127 127
Misdiagnosis 37 37
Insufficient Information 2 2
Test Result 1 1
No Information 1 1
Drug Resistant Bacterial Infection 1 1
Death 1 1
Unspecified Infection 1 1
Needle Stick/Puncture 1 1
Premature Labor 1 1
Chemical Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. II Dec-31-2020
2 Becton Dickinson & Co. II Feb-23-2019
3 Becton Dickinson & Co. II Nov-25-2017
4 BioMerieux SA II Jun-12-2018
5 Biomerieux Inc II Mar-25-2021
6 Biomerieux Inc II Aug-25-2017
7 Biomerieux Inc II May-22-2017
8 Organon Teknika Inc II Feb-27-2019
9 Remel Inc. II May-08-2020
10 bioMerieux, Inc. II Apr-12-2019
11 bioMerieux, Inc. II Feb-16-2019
12 bioMerieux, Inc. II Dec-19-2018
13 bioMerieux, Inc. II Dec-17-2018
14 bioMerieux, Inc. I Aug-30-2018
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