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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
Product CodeDOF
Regulation Number 862.3550
Device Class 2

MDR Year MDR Reports MDR Events
2018 40 40
2019 63 63
2020 2 2
2021 98 98
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Nonstandard Device 97 97
Incorrect, Inadequate or Imprecise Result or Readings 29 29
Low Test Results 16 16
Failure to Sense 14 14
Device Sensing Problem 14 14
False Negative Result 14 14
Battery Problem 9 9
Electrical /Electronic Property Problem 9 9
Complete Loss of Power 9 9
Failure to Run on Battery 6 6
Temperature Problem 5 5
Device Handling Problem 5 5
Material Integrity Problem 4 4
Corroded 4 4
Degraded 4 4
Electrical Overstress 4 4
Failure to Power Up 3 3
Overheating of Device 3 3
Imprecision 2 2
Calibration Problem 2 2
Noise, Audible 2 2
Power Problem 1 1
Product Quality Problem 1 1
Electrical Shorting 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Smoking 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 74 74
No Known Impact Or Consequence To Patient 62 62
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 20 20
No Patient Involvement 9 9
Test Result 9 9
Patient Problem/Medical Problem 6 6
No Information 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Burn(s) 1 1
Superficial (First Degree) Burn 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 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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