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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gram negative identification panel
Product CodeLQM
Regulation Number 866.2660
Device Class 1

MDR Year MDR Reports MDR Events
2015 69 69
2016 1 1
2017 77 77
2018 88 88
2019 12 12
2021 3 3
2022 7 7
2023 30 30
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Or Inadequate Test Results 161 161
Incorrect, Inadequate or Imprecise Result or Readings 119 119
Device Operates Differently Than Expected 7 7
Difficult to Open or Remove Packaging Material 6 6
False Positive Result 2 2
Appropriate Term/Code Not Available 2 2
Device Emits Odor 1 1
False Negative Result 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 92 92
No Known Impact Or Consequence To Patient 92 92
No Clinical Signs, Symptoms or Conditions 53 53
No Consequences Or Impact To Patient 45 45
Injury 6 6
Misdiagnosis 4 4
No Information 4 4
Pain 2 2
Not Applicable 2 2
Vomiting 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomerieux Inc II Jan-04-2023
2 Biomerieux Inc II May-22-2017
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