TPLC - Total Product Life Cycle

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Device	assay, enzyme linked immunosorbent, hepatitis c virus
Product Code	MZO
Device Class	2

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
11	12	40	24	16	10	14	19	16	17	11	13	8	0	0	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	464	464
Adverse Event Without Identified Device or Use Problem	105	105
Low Test Results	100	100
False Positive Result	50	50
No Apparent Adverse Event	35	35
Incorrect, Inadequate or Imprecise Result or Readings	30	30
High Test Results	28	28
Incorrect Or Inadequate Test Results	27	27
Nonstandard Device	8	8
Leak/Splash	2	2
Appropriate Term/Code Not Available	2	2
Non Reproducible Results	1	1
Incorrect Measurement	1	1
Use of Device Problem	1	1
False Reading From Device Non-Compliance	1	1
False Device Output	1	1
Output Problem	1	1
Low Readings	1	1
Chemical Problem	1	1
Device Operates Differently Than Expected	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	438	438
No Consequences Or Impact To Patient	159	159
No Clinical Signs, Symptoms or Conditions	154	154
No Information	31	31
No Code Available	30	30
Test Result	5	5
Hepatitis	5	5
Exposure to Body Fluids	2	2
Emotional Changes	1	1
Chemical Exposure	1	1
Misdiagnosis	1	1