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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device single (specified) analyte controls (assayed and unassayed)
Product CodeJJX
Regulation Number 862.1660
Device Class 1


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2017 19 19
2018 35 35
2019 82 82
2020 77 77
2021 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 210 210
High Test Results 14 14
Device Operates Differently Than Expected 7 7
Improper or Incorrect Procedure or Method 6 6
Output Problem 6 6
Nonstandard Device 6 6
Missing Information 5 5
Device Operational Issue 5 5
High Readings 5 5
Defective Device 2 2
Computer Software Problem 2 2
False Positive Result 2 2
Patient Data Problem 2 2
Sharp Edges 1 1
Physical Property Issue 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Premature Discharge of Battery 1 1
Use of Incorrect Control Settings 1 1
False Negative Result 1 1
Incorrect Or Inadequate Test Results 1 1
Low Test Results 1 1
Application Program Problem 1 1
Low Readings 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 171 171
No Clinical Signs, Symptoms or Conditions 59 59
No Patient Involvement 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hyperglycemia 3 3
Tissue Damage 2 2
Exposure to Body Fluids 2 2
Injury 2 2
No Code Available 1 1
Rupture 1 1
Unspecified Infection 1 1
Neuropathy 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-05-2020
2 Abbott Laboratories III Jul-25-2019
3 Abbott Laboratories III May-16-2019
4 Helena Laboratories, Inc. III Nov-30-2018
5 Medline Industries Inc III Feb-19-2021
6 Ortho-Clinical Diagnostics, Inc. III Nov-17-2021
7 Randox Laboratories Ltd. II Mar-15-2019
8 Sentinel CH SpA III Jul-06-2021
9 Siemens Healthcare Diagnostics, Inc II Feb-25-2017
10 Tosoh Bioscience Inc II Sep-14-2020
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