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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
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
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QURASENSE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 114 197
2020 13 13
2021 7 8
2022 8 8
2023 34 34
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 74 74
Incorrect, Inadequate or Imprecise Result or Readings 51 58
Mechanical Problem 43 116
Non Reproducible Results 24 25
Low Test Results 15 15
Decrease in Pressure 7 7
High Readings 5 5
Output Problem 4 4
Low Readings 4 4
No Apparent Adverse Event 4 4
Use of Device Problem 3 3
Leak/Splash 2 2
Smoking 2 2
Incorrect Measurement 2 2
Increase in Pressure 2 2
Chemical Problem 1 1
Pressure Problem 1 1
Fire 1 1
Insufficient Information 1 1
Fail-Safe Did Not Operate 1 1
Material Integrity Problem 1 1
Unable to Obtain Readings 1 2
Calibration Problem 1 1
Material Deformation 1 1
Data Problem 1 1
Computer Software Problem 1 1
Failure to Calibrate 1 1
False Positive Result 1 1
Mechanical Jam 1 3
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 102 185
No Clinical Signs, Symptoms or Conditions 93 94
No Consequences Or Impact To Patient 22 22
Test Result 1 1
Exposure to Body Fluids 1 1
No Patient Involvement 1 1
Hyperglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics Technologies AS II Aug-27-2024
2 Polymer Technology Systems II Dec-13-2019
3 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. II Oct-24-2024
4 Siemens Healthcare Diagnostics, Inc. II Mar-19-2024
5 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
6 Siemens Healthcare Diagnostics, Inc. II Jul-31-2020
7 Siemens Healthcare Diagnostics, Inc. II Jun-05-2020
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