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TPLC
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Device
hemoglobin a1c test system
Definition
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.
Product Code
PDJ
Regulation Number
862.1373
Device Class
2
Premarket Reviews
Manufacturer
Decision
BECKMAN COULTER IRELAND INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS OPERATIONS (RDO)
SUBSTANTIALLY EQUIVALENT
1
SHIJIAZHUANG HIPRO BIOTECHNOLOGY CO., LTD.
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
27
27
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
32
32
High Test Results
11
11
Low Test Results
5
5
Smoking
3
3
Patient Data Problem
3
3
Noise, Audible
3
3
Material Split, Cut or Torn
2
2
Display Difficult to Read
2
2
Leak/Splash
1
1
Device Ingredient or Reagent Problem
1
1
Fumes or Vapors
1
1
Image Display Error/Artifact
1
1
Insufficient Information
1
1
Defective Component
1
1
Device Emits Odor
1
1
No Apparent Adverse Event
1
1
Device Contamination with Chemical or Other Material
1
1
Low Readings
1
1
Improper or Incorrect Procedure or Method
1
1
Display or Visual Feedback Problem
1
1
No Device Output
1
1
Mechanical Problem
1
1
Device Contamination with Body Fluid
1
1
No Audible Alarm
1
1
High Readings
1
1
Infusion or Flow Problem
1
1
Power Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
64
64
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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