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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device method, enzymatic, glucose (urinary, non-quantitative)
Product CodeJIL
Regulation Number 862.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ARKRAY INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K183432  cobas u 601 urinalysis test system

MDR Year MDR Reports MDR Events
2019 67 67
2020 23 23
2021 12 12
2022 14 14
2023 15 15
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 36 36
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
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
Computer Software Problem 1 1
Incorrect Measurement 1 1
No Device Output 1 1
Overheating of Device 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 54 54
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
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