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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument for auto reader & interpretation of overnight suscept. systems
Product CodeLRG
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
THERMO FISHER SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 2
TREK DIAGNOSTIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TREK DIAGNOSTIC SYSTEMS, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 31 31
2015 30 30
2016 1 1
2017 1 1
2019 3 3
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Product Quality Problem 14 14
Incorrect Or Inadequate Test Results 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Nonstandard Device 7 7
Device Emits Odor 2 2
Break 2 2
Fire 2 2
Smoking 2 2
Device Handling Problem 2 2
Output Problem 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Device Slipped 1 1
Application Program Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Operates Differently Than Expected 1 1
Electrical Shorting 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Mechanical Problem 1 1
False Negative Result 1 1
False Device Output 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 19 19
Not Applicable 19 19
No Patient Involvement 18 18
No Information 3 3
No Consequences Or Impact To Patient 3 3
Injury 2 2
Reaction 1 1
Chemical Exposure 1 1
Eye Injury 1 1
Septic Shock 1 1
Urinary Tract Infection 1 1
Collagen disease 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II May-13-2022
2 Beckman Coulter Inc. II Apr-07-2021
3 Beckman Coulter Inc. II Dec-23-2020
4 Siemens Healthcare Diagnostics, Inc. II Jul-02-2014
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