TPLC - Total Product Life Cycle

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Device	system, test, automated blood grouping and antibody
Regulation Description	Automated blood grouping and antibody test system.
Product Code	KSZ
Regulation Number	864.9175
Device Class	2

Premarket Reviews
Manufacturer	Decision
BECKMAN COULTER, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIO RAD MEDICAL DIAGNOSTICS GMBH
	SUBSTANTIALLY EQUIVALENT	2
BIO-RAD MEDICAL DIAGNOSTICS GMBH
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOSTIC GRIFOLS, S. A.
	SUBSTANTIALLY EQUIVALENT	7
DIAGNOSTIC GRIFOLS, S.A.
	SUBSTANTIALLY EQUIVALENT	3
IMMUCOR, INC.
	SUBSTANTIALLY EQUIVALENT	11
ORTHO-CLINICAL DIAGNOSTICS, INC.
	SUBSTANTIALLY EQUIVALENT	5
STRATEC BIOMEDICAL UK LIMITED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	165	657
Incorrect, Inadequate or Imprecise Result or Readings	144	184
False Positive Result	96	237
Adverse Event Without Identified Device or Use Problem	51	51
Computer Software Problem	11	11
Improper or Incorrect Procedure or Method	11	11
Low Readings	9	9
Contamination	7	7
Electrical /Electronic Property Problem	6	6
Leak/Splash	5	5
Non Reproducible Results	5	12
Defective Device	4	4
Alarm Not Visible	4	4
Device Displays Incorrect Message	3	3
Insufficient Information	3	3
Device Contamination with Chemical or Other Material	3	3
Output Problem	3	3
Sparking	2	2
Arcing	2	2
No Apparent Adverse Event	2	2
Mechanical Problem	2	2
Defective Component	2	2
Naturally Worn	2	2
Erratic Results	2	2
Data Problem	2	2
Arcing of Electrodes	2	2
Failure to Read Input Signal	2	2
Positioning Failure	1	1
Circuit Failure	1	1
Misassembly During Maintenance/Repair	1	1
Missing Test Results	1	1
Image Display Error/Artifact	1	1
Incorrect Measurement	1	1
Noise, Audible	1	1
Material Integrity Problem	1	1
Failure to Power Up	1	1
Failure to Transmit Record	1	1
Nonstandard Device	1	1
Unintended Electrical Shock	1	1
Failure to Clean Adequately	1	1
Therapeutic or Diagnostic Output Failure	1	1
Excess Flow or Over-Infusion	1	1
Power Problem	1	1
Coagulation in Device or Device Ingredient	1	1
Use of Device Problem	1	1
Smoking	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	407	766
No Known Impact Or Consequence To Patient	38	53
Insufficient Information	31	195
No Consequences Or Impact To Patient	13	13
Test Result	7	14
Hemorrhage/Bleeding	2	2
Exposure to Body Fluids	2	2
Chest Pain	1	1
Nausea	1	1
Hypersensitivity/Allergic reaction	1	1
Non specific EKG/ECG Changes	1	1
Fever	1	1
Chills	1	1
Hemolysis	1	1
Reaction	1	1
Shaking/Tremors	1	1
Bone Fracture(s)	1	1
Hearing Loss	1	1
Laceration(s)	1	1
High Blood Pressure/ Hypertension	1	1
Reaction to Medicinal Component of Device	1	1
Electric Shock	1	1
Unspecified Tissue Injury	1	1
Headache	1	1