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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, glycosylated hemoglobin
Product CodeLCP
Regulation Number 864.7470
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT RAPID DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASAHI KASEI PHARMA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIOHERMES CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
DRAWBRIDGE HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
EKF-DIAGNOSTIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
IXENSOR CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
IXENSOR CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JANA CARE, INC
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS
  SUBSTANTIALLY EQUIVALENT 1
SEBIA
  SUBSTANTIALLY EQUIVALENT 1
SKYLA CORPORATION H.S.P.B.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 147 147
2018 1908 1908
2019 114 197
2020 13 13
2021 7 8
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 626 626
Device Operational Issue 465 465
Device Displays Incorrect Message 441 441
Device Issue 315 315
Mechanical Problem 231 304
Incorrect, Inadequate or Imprecise Resultor Readings 140 147
Increase in Pressure 95 95
Incorrect Or Inadequate Test Results 79 79
Pressure Problem 72 72
Decrease in Pressure 63 63
Use of Device Problem 59 59
Leak/Splash 43 43
High Test Results 38 38
Computer Software Problem 18 18
Low Test Results 17 17
Calibration Problem 14 14
Fluid Leak 14 14
Noise, Audible 13 13
Output Problem 12 12
High Readings 12 12
Connection Problem 12 12
Low Readings 9 9
Failure to Align 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Break 9 9
Imprecision 8 8
Obstruction of Flow 8 8
Occlusion Within Device 7 7
Complete Blockage 7 7
Physical Property Issue 7 7
Device Maintenance Issue 6 6
Failure to Calibrate 6 6
No Pressure 6 6
Device Ingredient or Reagent Problem 5 5
Contamination of Device Ingredient or Reagent 5 5
Bent 5 5
Non Reproducible Results 5 6
Mechanical Jam 4 6
No Apparent Adverse Event 4 4
Partial Blockage 4 4
Image Resolution Poor 4 4
Fitting Problem 4 4
Material Integrity Problem 3 3
Loose or Intermittent Connection 3 3
Calibration Error 3 3
Detachment Of Device Component 2 2
No Display/Image 2 2
Electrical /Electronic Property Problem 2 2
Fire 2 2
Inaccurate Flow Rate 2 2
Poor Quality Image 2 2
Inadequate User Interface 2 2
Infusion or Flow Problem 2 2
Issue With Displayed Error Message 2 2
Material Deformation 2 2
Communication or Transmission Problem 2 2
Computer Operating System Problem 2 2
Smoking 2 2
Loss of Data 2 2
Data Problem 2 2
Temperature Problem 2 2
Power Problem 1 1
Missing Test Results 1 1
Appropriate Term/Code Not Available 1 1
Fail-Safe Did Not Operate 1 1
Delamination 1 1
Detachment of Device or Device Component 1 1
Device Contamination With Biological Material 1 1
Malposition of Device 1 1
Folded 1 1
Inadequate or Insufficient Training 1 1
Date/Time-Related Software Problem 1 1
Device Sensing Problem 1 1
Filtration Problem 1 1
Human Factors Issue 1 1
Incorrect Error Code 1 1
Material Twisted/Bent 1 1
Operating System Becomes Nonfunctional 1 1
Material Separation 1 1
Unable to Obtain Readings 1 2
Failure to Recalibrate 1 1
Difficult to Remove 1 1
Incorrect Measurement 1 1
Misconnection 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Display or Visual Feedback Problem 1 1
Air Leak 1 1
Device Alarm System 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2127 2210
No Consequences Or Impact To Patient 36 36
No Information 15 15
No Clinical Signs, Symptoms or Conditions 14 15
Therapeutic Response, Decreased 2 2
Test Result 2 2
No Patient Involvement 1 1
Missing Value Reason 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Polymer Technology Systems II Dec-13-2019
2 Randox Laboratories Ltd. II Dec-22-2017
3 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
4 Siemens Healthcare Diagnostics, Inc. II Jul-31-2020
5 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
6 Tosoh Bioscience Inc III Dec-13-2018
7 Tosoh Bioscience Inc II Sep-25-2018
8 Tosoh Bioscience Inc II Aug-11-2018
9 Tosoh Bioscience Inc II May-14-2018
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