TPLC - Total Product Life Cycle

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Device	insulin pump secondary display
Definition	The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Product Code	PKU
Regulation Number	862.1350
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	17970	17971
Computer Software Problem	8633	8633
Appropriate Term/Code Not Available	1543	1543
Communication or Transmission Problem	1085	1085
Application Network Problem	119	119
Device Alarm System	44	44
Problem with Software Installation	44	44
No Apparent Adverse Event	36	36
Unauthorized Access to Computer System	8	8
Adverse Event Without Identified Device or Use Problem	4	4
Application Program Problem	3	3
Data Problem	3	3
Break	2	2
Power Problem	2	2
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Battery Problem	1	1
Moisture or Humidity Problem	1	1
Erratic or Intermittent Display	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	25037	25038
Insufficient Information	517	517
Hyperglycemia	100	100
Hypoglycemia	73	73
Discomfort	20	20
Hemorrhage/Bleeding	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Diabetic Ketoacidosis	4	4
Bruise/Contusion	4	4
Confusion/ Disorientation	3	3
Itching Sensation	2	2
Loss of consciousness	2	2
Abdominal Pain	1	1
Skin Infection	1	1
Nausea	1	1
Hematoma	1	1
Vomiting	1	1
Dyspnea	1	1
Anxiety	1	1
Shaking/Tremors	1	1
Hypoglycemic Shock	1	1
Joint Contracture	1	1
Headache	1	1