TPLC - Total Product Life Cycle

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Device	system, test, human chorionic gonadotropin
Product Code	DHA
Regulation Number	862.1155
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT LABORATORIES
	SUBSTANTIALLY EQUIVALENT	2
BECKMAN COULTER, INC
	SUBSTANTIALLY EQUIVALENT	1
DIAZYME LABORATORIES INC.
	SUBSTANTIALLY EQUIVALENT	1
ROCHE DIAGNOSTICS
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN YHLO BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
	SUBSTANTIALLY EQUIVALENT	1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	479	479
High Test Results	266	266
Low Test Results	88	88
Non Reproducible Results	65	65
False Negative Result	60	60
Incorrect, Inadequate or Imprecise Result or Readings	38	38
Incorrect Measurement	13	13
No Apparent Adverse Event	5	5
Output Problem	2	2
High Readings	2	2
Low Readings	2	2
Material Integrity Problem	1	1
Product Quality Problem	1	1
Unable to Obtain Readings	1	1
Insufficient Information	1	1
Data Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	633	633
No Known Impact Or Consequence To Patient	178	178
No Consequences Or Impact To Patient	43	43
Abdominal Pain	19	19
No Information	14	14
Nausea	10	10
Vomiting	7	7
Pain	6	6
Insufficient Information	6	6
No Patient Involvement	5	5
Headache	4	4
Misdiagnosis	3	3
Diarrhea	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Code Available	3	3
Decreased Appetite	2	2
Intermenstrual Bleeding	2	2
Test Result	2	2
Ectopic Pregnancy	2	2
Anxiety	2	2
Numbness	2	2
Cyst(s)	2	2
Lupus	2	2
Memory Loss/Impairment	1	1
Weakness	1	1
Syncope	1	1
Unspecified Infection	1	1
Decreased Respiratory Rate	1	1
Sleep Dysfunction	1	1
Dyskinesia	1	1
Dysphasia	1	1
Complete Induced Abortion	1	1
Edema	1	1
Fever	1	1
Abscess	1	1
Anemia	1	1
Stroke/CVA	1	1
Chest Pain	1	1
Congestive Heart Failure	1	1
Renal Disease, End Stage	1	1
Sepsis	1	1
Septic Shock	1	1
Spinal Column Injury	1	1
Swelling	1	1
Vertigo	1	1
Visual Impairment	1	1
Dysuria	1	1
Lymphoma	1	1
Hallucination	1	1
Cough	1	1
Pancreatitis	1	1
Genital Bleeding	1	1
Cramp(s) /Muscle Spasm(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Laboratories	III	Jan-17-2023
2	Siemens Healthcare Diagnostics, Inc.	II	Apr-28-2022