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	578	578
High Test Results	326	326
Non Reproducible Results	161	161
Low Test Results	158	158
False Negative Result	70	70
Incorrect, Inadequate or Imprecise Result or Readings	52	52
Incorrect Measurement	26	26
Output Problem	7	7
No Apparent Adverse Event	5	5
Insufficient Information	3	3
Material Integrity Problem	3	3
High Readings	2	2
Chemical Problem	1	1
Mechanical Problem	1	1
Erratic Results	1	1
Unable to Obtain Readings	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Data Problem	1	1
Product Quality Problem	1	1
Low Readings	1	1
Failure to Calibrate	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1009	1009
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
Dysphasia	1	1
Sleep Dysfunction	1	1
Syncope	1	1
Ectopic Pregnancy	1	1
Pancreatitis	1	1
Dysuria	1	1
Genital Bleeding	1	1
Memory Loss/Impairment	1	1
Complete Induced Abortion	1	1
No Information	1	1
Cyst(s)	1	1
Intermenstrual Bleeding	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Spinal Column Injury	1	1
Chest Pain	1	1
Septic Shock	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