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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 DIAGNOSTICS TECHNOLOGIES AS
  SUBSTANTIALLY EQUIVALENT 1
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
  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
SKYLA CORPORATION H.S.P.B.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1909 1909
2019 114 197
2020 13 13
2021 7 8
2022 8 8
2023 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 621 621
Device Displays Incorrect Message 432 432
Device Operational Issue 359 359
Device Issue 296 296
Mechanical Problem 228 301
Incorrect, Inadequate or Imprecise Result or Readings 135 142
Increase in Pressure 94 94
Incorrect Or Inadequate Test Results 77 77
Pressure Problem 72 72
Decrease in Pressure 63 63
Use of Device Problem 59 59
High Test Results 45 45
Leak/Splash 43 43
Computer Software Problem 18 18
Low Test Results 17 17
Fluid/Blood Leak 14 14
Calibration Problem 13 13
Noise, Audible 13 13
Non Reproducible Results 12 13
Output Problem 12 12
High Readings 12 12
Failure to Align 9 9
Connection Problem 9 9
Break 9 9
Obstruction of Flow 8 8
Low Readings 8 8
Complete Blockage 7 7
Occlusion Within Device 7 7
Imprecision 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
Partial Blockage 4 4
Image Resolution Poor 4 4
Material Integrity Problem 4 4
Fitting Problem 4 4
No Apparent Adverse Event 4 4
Mechanical Jam 4 6
Calibration Error 3 3
Detachment Of Device Component 2 2
Fire 2 2
Inaccurate Flow Rate 2 2
No Display/Image 2 2
Incorrect Measurement 2 2
Poor Quality Image 2 2
Communication or Transmission Problem 2 2
Computer Operating System Problem 2 2
Smoking 2 2
Infusion or Flow Problem 2 2
Issue With Displayed Error Message 2 2
Material Deformation 2 2
Loss of Data 2 2
Data Problem 2 2
Missing Test Results 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Power Problem 1 1
Temperature Problem 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
Device Sensing Problem 1 1
Filtration Problem 1 1
Incorrect Error Code 1 1
Material Twisted/Bent 1 1
Operating System Becomes Nonfunctional 1 1
Malposition of Device 1 1
Folded 1 1
Date/Time-Related Software Problem 1 1
Material Separation 1 1
Unable to Obtain Readings 1 2
Failure to Recalibrate 1 1
Difficult to Remove 1 1
Loose or Intermittent Connection 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
Electrical /Electronic Property 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 1987 2070
No Clinical Signs, Symptoms or Conditions 42 43
No Consequences Or Impact To Patient 29 29
No Information 13 13
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 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
3 Siemens Healthcare Diagnostics, Inc. II Jul-31-2020
4 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
5 Tosoh Bioscience Inc III Dec-13-2018
6 Tosoh Bioscience Inc II Sep-25-2018
7 Tosoh Bioscience Inc II Aug-11-2018
8 Tosoh Bioscience Inc II May-14-2018
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