TPLC - Total Product Life Cycle

show TPLC since

Device	method, enzymatic, glucose (urinary, non-quantitative)
Product Code	JIL
Regulation Number	862.1340
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Negative Result	39	39
False Positive Result	21	21
Smoking	19	19
Low Test Results	17	17
High Test Results	13	13
Electrical /Electronic Property Problem	10	10
Non Reproducible Results	8	8
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Missing Information	5	5
Patient Data Problem	2	2
Device Difficult to Setup or Prepare	2	2
No Device Output	2	2
Optical Problem	2	2
Temperature Problem	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
High Readings	1	1
Low Readings	1	1
Device Markings/Labelling Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Overheating of Device	1	1
Computer Software Problem	1	1
Incorrect Measurement	1	1
Missing Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	69	69
No Clinical Signs, Symptoms or Conditions	57	57
No Patient Involvement	11	11
No Known Impact Or Consequence To Patient	6	6
Insufficient Information	2	2
Urinary Tract Infection	1	1
Pregnancy	1	1
Urinary Frequency	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Macherey Nagel Gmbh & Co. Kg	II	May-16-2024