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	43	43
False Positive Result	22	22
Smoking	20	20
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	7	7
Missing Information	5	5
Patient Data Problem	2	2
Device Difficult to Setup or Prepare	2	2
Optical Problem	2	2
No Device Output	2	2
Device Markings/Labelling Problem	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
High Readings	1	1
Missing Test Results	1	1
Incorrect Measurement	1	1
Low Readings	1	1
No Apparent Adverse Event	1	1
Computer Software Problem	1	1
Overheating of Device	1	1
Temperature Problem	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	63	63
No Patient Involvement	11	11
No Known Impact Or Consequence To Patient	6	6
Insufficient Information	2	2
Pregnancy	1	1
Urinary Frequency	1	1
Urinary Tract Infection	1	1
Distress	1	1

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