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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
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 1908 1908
2019 114 197
2020 13 13
2021 7 8
2022 8 8
2023 2 2

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 227 300
Incorrect, Inadequate or Imprecise Result or Readings 132 139
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 58 58
Leak/Splash 43 43
High Test Results 28 28
Computer Software Problem 18 18
Low Test Results 15 15
Fluid/Blood Leak 14 14
Calibration Problem 13 13
Noise, Audible 13 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
Non Reproducible Results 6 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
Fitting Problem 4 4
No Apparent Adverse Event 4 4
Mechanical Jam 4 6
Material Integrity Problem 3 3
Calibration Error 3 3
Detachment Of Device Component 2 2
Fire 2 2
Inaccurate Flow Rate 2 2
No Display/Image 2 2
Poor Quality Image 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
Communication or Transmission Problem 2 2
Computer Operating System Problem 2 2
Data Problem 2 2
Missing Test Results 1 1
Fail-Safe Did Not Operate 1 1
Appropriate Term/Code Not Available 1 1
Power Problem 1 1
Malposition of Device 1 1
Folded 1 1
Date/Time-Related Software Problem 1 1
Material Separation 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
Unable to Obtain Readings 1 2
Failure to Recalibrate 1 1
Difficult to Remove 1 1
Incorrect Measurement 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 Consequences Or Impact To Patient 29 29
No Clinical Signs, Symptoms or Conditions 18 19
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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