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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
Regulation Description 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
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MEDCONN MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TOSOH BIOSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 5 5
2021 6 6
2022 19 19
2023 16 16
2024 47 47
2025 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 58 58
High Test Results 17 17
Low Test Results 11 11
Non Reproducible Results 4 4
Smoking 4 4
Appropriate Term/Code Not Available 4 4
Patient Data Problem 3 3
Noise, Audible 3 3
Device Ingredient or Reagent Problem 2 2
Material Split, Cut or Torn 2 2
Display Difficult to Read 2 2
High Readings 2 2
Leak/Splash 1 1
Fumes or Vapors 1 1
Sparking 1 1
Fire 1 1
Mechanical Problem 1 1
Device Contamination with Body Fluid 1 1
Image Display Error/Artifact 1 1
Device Markings/Labelling Problem 1 1
Insufficient Information 1 1
Defective Component 1 1
No Audible Alarm 1 1
Use of Device Problem 1 1
Infusion or Flow Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Device Emits Odor 1 1
Low Readings 1 1
Device Contamination with Chemical or Other Material 1 1
No Apparent Adverse Event 1 1
Power Problem 1 1
Human-Device Interface Problem 1 1
Display or Visual Feedback Problem 1 1
Improper or Incorrect Procedure or Method 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 114 114
Hyperglycemia 4 4
Insufficient Information 2 2
No Consequences Or Impact To Patient 2 2
Misdiagnosis 1 1
Chest Pain 1 1
Myocardial Infarction 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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