TPLC - Total Product Life Cycle

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Device	culture media, non-selective and non-differential
Product Code	JSG
Regulation Number	866.2300
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	249	249
Contamination	184	184
Contamination of Device Ingredient or Reagent	53	53
Device Markings/Labelling Problem	40	40
Microbial Contamination of Device	17	17
Device Contamination with Chemical or Other Material	10	10
Missing Information	5	5
Contamination /Decontamination Problem	3	3
False Negative Result	3	3
Fluid/Blood Leak	3	3
False Positive Result	2	2
Material Opacification	2	2
Output Problem	2	2
Protective Measures Problem	1	1
Separation Problem	1	1
Inaccurate Information	1	1
Break	1	1
Particulates	1	1
Product Quality Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Leak/Splash	1	1
Connection Problem	1	1
Component Missing	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	535	535
No Known Impact Or Consequence To Patient	21	21
No Consequences Or Impact To Patient	11	11
No Patient Involvement	7	7
Insufficient Information	4	4
Bacterial Infection	2	2
Unspecified Infection	1	1
Injury	1	1
Prolapse	1	1