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 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

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
Fumes or Vapors	1	1
Device Ingredient or Reagent Problem	1	1
Image Display Error/Artifact	1	1
Insufficient Information	1	1
Defective Component	1	1
No Audible Alarm	1	1
High Readings	1	1
Infusion or Flow Problem	1	1
Device Emits Odor	1	1
No Apparent Adverse Event	1	1
Low Readings	1	1
Device Contamination with Chemical or Other Material	1	1
Display or Visual Feedback Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Mechanical Problem	1	1
Device Contamination with Body Fluid	1	1
Power Problem	1	1
No Device Output	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