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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reagent red blood cells
Definition For the detection of or identification of human blood-group antibodies
Product CodeQHT
Regulation Number 660.30
Device Class Unclassified

MDR Year MDR Reports MDR Events
2018 3 3
2019 14 40
2020 89 172
2021 60 60
2022 48 48
2023 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 169 277
Adverse Event Without Identified Device or Use Problem 37 37
Incorrect, Inadequate or Imprecise Result or Readings 23 23
False Positive Result 15 16
Defective Device 3 3
Improper Chemical Reaction 2 2
Defective Component 1 1
Break 1 1
Cross Reactivity 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Erratic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 158 158
No Known Impact Or Consequence To Patient 69 125
Test Result 9 62
Chills 5 5
No Consequences Or Impact To Patient 5 5
Reaction 4 4
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Fever 2 2
Nausea 2 2
Therapeutic Effects, Unexpected 1 1
Jaundice 1 1
Laceration(s) 1 1
Chest Pain 1 1

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