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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lead, atomic absorption
Regulation Description Lead test system.
Product CodeDOF
Regulation Number 862.3550
Device Class 2

MDR Year MDR Reports MDR Events
2017 39 39
2018 40 40
2019 63 63
2020 2 2
2021 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 72 72
Device Sensing Problem 30 30
Incorrect, Inadequate or Imprecise Resultor Readings 29 29
Failure to Sense 27 27
False Negative Result 26 26
Low Test Results 17 17
Battery Problem 13 13
Complete Loss of Power 9 9
Electrical /Electronic Property Problem 9 9
Failure to Run on Battery 6 6
Temperature Problem 5 5
Device Handling Problem 5 5
Noise, Audible 5 5
Material Integrity Problem 4 4
Electrical Overstress 4 4
Failure to Power Up 4 4
Overheating of Device 4 4
Corroded 4 4
Degraded 4 4
Bent 3 3
Calibration Problem 3 3
Electrical Shorting 3 3
Improper or Incorrect Procedure or Method 2 2
Imprecision 2 2
Leak/Splash 2 2
Smoking 2 2
Use of Device Problem 1 1
Product Quality Problem 1 1
Moisture Damage 1 1
False Positive Result 1 1
Fluid Leak 1 1
Power Problem 1 1
Improper Chemical Reaction 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Electrical Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 94 94
Insufficient Information 50 50
No Consequences Or Impact To Patient 26 26
No Clinical Signs, Symptoms or Conditions 23 23
No Patient Involvement 9 9
Test Result 9 9
Patient Problem/Medical Problem 6 6
No Information 5 5
Burn(s) 1 1
Superficial (First Degree) Burn 1 1
Burn, Thermal 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Magellan Diagnostics, Inc. I Jul-01-2021
2 Magellan Diagnostics, Inc. II Oct-26-2018
3 Magellan Diagnostics, Inc. II Apr-03-2018
4 Magellan Diagnostics, Inc. II Aug-15-2017
5 Magellan Diagnostics, Inc. I Jun-05-2017
6 Magellan Diagnostics, Inc. I May-18-2017
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