TPLC - Total Product Life Cycle

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Device	culture media, antimicrobial susceptibility test, excluding mueller hinton agar
Product Code	JSO
Regulation Number	866.1700
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	81	81
False Positive Result	39	39
Incorrect Or Inadequate Test Results	28	28
False Negative Result	18	18
Contamination	4	4
Defective Device	3	3
Contamination of Device Ingredient or Reagent	3	3
Device Markings/Labelling Problem	2	2
Device Contamination with Chemical or Other Material	1	1
Output Problem	1	1
Material Discolored	1	1
Break	1	1
Incorrect Measurement	1	1
Nonstandard Device	1	1
Unable to Obtain Readings	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	72	72
No Clinical Signs, Symptoms or Conditions	44	44
No Consequences Or Impact To Patient	34	34
No Patient Involvement	14	14
Misdiagnosis	7	7
No Code Available	4	4
Missed Dose	3	3
Bacterial Infection	1	1
Staphylococcus Aureus	1	1
Drug Resistant Bacterial Infection	1	1
Insufficient Information	1	1