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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
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 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 51 51
Incorrect, Inadequate or Imprecise Result or Readings 48 55
Mechanical Problem 42 115
Non Reproducible Results 18 19
Low Test Results 13 13
Decrease in Pressure 7 7
High Readings 4 4
No Apparent Adverse Event 4 4
Use of Device Problem 3 3
Low Readings 3 3
Increase in Pressure 2 2
Smoking 2 2
Output Problem 2 2
Incorrect Measurement 2 2
Fail-Safe Did Not Operate 1 1
Pressure Problem 1 1
Insufficient Information 1 1
Data Problem 1 1
Failure to Calibrate 1 1
Unable to Obtain Readings 1 2
Computer Software Problem 1 1
Fire 1 1
Fluid/Blood Leak 1 1
Leak/Splash 1 1
Calibration Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanical Jam 1 3

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 63 64
No Consequences Or Impact To Patient 22 22
No Patient Involvement 1 1
Test Result 1 1
Hyperglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Polymer Technology Systems II Dec-13-2019
2 Siemens Healthcare Diagnostics, Inc. II Mar-19-2024
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
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