TPLC - Total Product Life Cycle

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Device	system, test, human chorionic gonadotropin
Regulation Description	Human chorionic gonadotropin (HCG) test system.
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
ORTHO CLINICAL DIAGNOSTICS
	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

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	506	506
High Test Results	299	299
Low Test Results	129	129
Non Reproducible Results	128	128
False Negative Result	63	63
Incorrect, Inadequate or Imprecise Result or Readings	45	45
Incorrect Measurement	22	22
Output Problem	7	7
No Apparent Adverse Event	5	5
Unable to Obtain Readings	2	2
High Readings	2	2
Material Integrity Problem	2	2
Low Readings	1	1
Chemical Problem	1	1
Product Quality Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Data Problem	1	1
Failure to Calibrate	1	1
Erratic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	879	879
No Known Impact Or Consequence To Patient	91	91
Abdominal Pain	14	14
No Consequences Or Impact To Patient	11	11
Nausea	9	9
Insufficient Information	9	9
Vomiting	6	6
No Patient Involvement	4	4
Pain	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Misdiagnosis	3	3
Diarrhea	3	3
Anxiety	3	3
Numbness	2	2
Headache	2	2
Decreased Appetite	2	2
Sleep Dysfunction	1	1
Dysphasia	1	1
Syncope	1	1
Ectopic Pregnancy	1	1
Pancreatitis	1	1
Genital Bleeding	1	1
Dysuria	1	1
No Information	1	1
Complete Induced Abortion	1	1
Memory Loss/Impairment	1	1
Cyst(s)	1	1
Intermenstrual Bleeding	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Spinal Column Injury	1	1
Septic Shock	1	1
Chest Pain	1	1
Lymphoma	1	1
Cough	1	1
Decreased Respiratory Rate	1	1
Hallucination	1	1

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