TPLC - Total Product Life Cycle

show TPLC since

Device	covid-19 multi-analyte respiratory panel nucleic acid devices
Definition	Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.
Product Code	QLT
Device Class	Not Classified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Non Reproducible Results	917	917
False Positive Result	737	737
Incorrect, Inadequate or Imprecise Result or Readings	388	388
Output Problem	354	354
False Negative Result	50	50
No Apparent Adverse Event	17	17
Erratic Results	13	13
No Device Output	5	5
Unable to Obtain Readings	4	4
Insufficient Information	4	4
Device Sensing Problem	2	2
Unexpected Therapeutic Results	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1647	1647
Anxiety	564	564
Unspecified Respiratory Problem	563	563
Insufficient Information	3	3