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	254	254
Contamination	184	184
Contamination of Device Ingredient or Reagent	57	57
Device Markings/Labelling Problem	49	49
Microbial Contamination of Device	19	19
Device Contamination with Chemical or Other Material	12	12
Missing Information	6	6
Contamination /Decontamination Problem	3	3
False Negative Result	3	3
Fluid/Blood Leak	3	3
False Positive Result	2	2
Material Opacification	2	2
Device Contaminated During Manufacture or Shipping	2	2
Output Problem	2	2
Protective Measures Problem	1	1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient	1	1
Insufficient Information	1	1
Separation Problem	1	1
Inaccurate Information	1	1
Break	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Connection Problem	1	1
Component Missing	1	1
Particulates	1	1
Product Quality Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	557	557
No Known Impact Or Consequence To Patient	24	24
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
Increased Sensitivity	1	1
Injury	1	1
Prolapse	1	1
No Information	1	1