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TPLC
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Device
method, enzymatic, glucose (urinary, non-quantitative)
Product Code
JIL
Regulation Number
862.1340
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARKRAY INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
67
67
2020
23
23
2021
12
12
2022
14
14
2023
15
15
2024
18
18
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Negative Result
41
41
False Positive Result
21
21
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
6
6
Missing Information
5
5
Device Difficult to Setup or Prepare
2
2
Optical Problem
2
2
No Device Output
2
2
Patient Data Problem
2
2
Incorrect Measurement
2
2
Insufficient Information
1
1
High Readings
1
1
Missing Test Results
1
1
Overheating of Device
1
1
Temperature Problem
1
1
Device Markings/Labelling Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
No Apparent Adverse Event
1
1
Low Readings
1
1
Computer Software 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
61
61
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
Recalls
Manufacturer
Recall Class
Date Posted
1
Macherey Nagel Gmbh & Co. Kg
II
May-16-2024
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