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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hemoglobin a1c test system
Definition Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Product CodePDJ
Regulation Number 862.1373
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER IRELAND INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 6 6
2022 19 19
2023 16 16
2024 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 25 25
High Test Results 11 11
Low Test Results 3 3
Smoking 3 3
Patient Data Problem 3 3
Noise, Audible 2 2
Display Difficult to Read 2 2
Display or Visual Feedback Problem 1 1
Image Display Error/Artifact 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Device Emits Odor 1 1
No Device Output 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
Low Readings 1 1
Fumes or Vapors 1 1
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Power Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
No Audible Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 52 52
Hyperglycemia 4 4
No Consequences Or Impact To Patient 2 2
Insufficient Information 2 2
Myocardial Infarction 1 1
Misdiagnosis 1 1
Chest Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diagnostics Technologies AS II May-29-2020
2 Abbott Laboratories II Jul-22-2022
3 Ortho-Clinical Diagnostics, Inc. II May-24-2023
4 Siemens Healthcare Diagnostics, Inc. II Apr-14-2022
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