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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion specific, potassium
Product CodeCEM
Regulation Number 862.1600
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAMOND DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 32 32
2018 13 13
2019 25 25
2020 27 27
2021 18 18
2022 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 36 36
Low Test Results 25 25
Low Readings 12 12
Mechanical Problem 12 12
Incorrect, Inadequate or Imprecise Resultor Readings 10 10
Insufficient Information 8 8
Use of Device Problem 7 7
High Readings 7 7
Adverse Event Without Identified Device or Use Problem 4 4
Smoking 3 3
Erratic Results 2 2
Non Reproducible Results 2 2
Thermal Decomposition of Device 1 1
Computer Software Problem 1 1
Component Misassembled 1 1
Incorrect Or Inadequate Test Results 1 1
Calibration Problem 1 1
Overheating of Device 1 1
Electrical Shorting 1 1
Defective Component 1 1
Device Contamination with Body Fluid 1 1
False Reading From Device Non-Compliance 1 1
Material Fragmentation 1 1
Unexpected Shutdown 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 51 51
No Consequences Or Impact To Patient 31 31
No Clinical Signs, Symptoms or Conditions 31 31
Test Result 3 3
Death 3 3
Laceration(s) 2 2
Injury 2 2
Electric Shock 1 1
No Code Available 1 1
Abrasion 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jun-03-2020
2 Inpeco S.A. II Oct-12-2021
3 Inpeco S.A. II Nov-06-2020
4 Inpeco S.A. II Sep-16-2020
5 Inpeco S.A. II Jun-01-2020
6 Inpeco S.A. II May-26-2020
7 Inpeco S.A. II May-14-2020
8 Ortho-Clinical Diagnostics II Nov-01-2019
9 Radiometer America Inc II Aug-22-2019
10 Radiometer Medical ApS II Jun-15-2021
11 Radiometer Medical ApS II Apr-22-2020
12 Randox Laboratories Ltd. II Jul-26-2021
13 Roche Diagnostics Corporation II May-03-2018
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