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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
2022 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 223 223
High Test Results 14 14
Device Operates Differently Than Expected 7 7
Improper or Incorrect Procedure or Method 6 6
Nonstandard Device 6 6
Output Problem 6 6
High Readings 5 5
Missing Information 5 5
Device Operational Issue 5 5
Patient Data Problem 2 2
False Positive Result 2 2
Computer Software Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Appropriate Term/Code Not Available 2 2
Defective Device 2 2
Use of Device Problem 1 1
Incorrect Or Inadequate Test Results 1 1
Physical Property Issue 1 1
Insufficient Information 1 1
Sharp Edges 1 1
Premature Discharge of Battery 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Application Program Problem 1 1
Use of Incorrect Control Settings 1 1
False Negative Result 1 1
Low Test Results 1 1
Low Readings 1 1
Data 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 72 72
No Patient Involvement 14 14
Hyperglycemia 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Injury 2 2
Exposure to Body Fluids 2 2
Tissue Damage 2 2
Rupture 1 1
Erythema 1 1
Hypoglycemia 1 1
Unspecified Infection 1 1
Neuropathy 1 1
Red Eye(s) 1 1
No Code Available 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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