Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
calculator/data processing module, for clinical use
Product Code
JQP
Regulation Number
862.2100
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
253
254
2020
52
52
2021
105
105
2022
166
166
2023
173
173
2024
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
176
176
Missing Information
173
173
Computer Software Problem
84
84
Application Program Problem
47
47
Patient Data Problem
46
46
Product Quality Problem
37
37
Insufficient Information
22
22
Data Problem
16
16
Smoking
11
11
Use of Device Problem
11
11
Low Test Results
11
12
False Negative Result
11
11
False Positive Result
10
10
Installation-Related Problem
10
10
Fail-Safe Problem
10
10
Adverse Event Without Identified Device or Use Problem
8
8
Thermal Decomposition of Device
7
7
High Test Results
7
7
No Apparent Adverse Event
7
7
Non Reproducible Results
7
7
Output Problem
5
5
Unintended Movement
5
5
Mechanical Jam
4
4
Communication or Transmission Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Overheating of Device
4
4
Mechanical Problem
4
4
Leak/Splash
3
3
Electrical /Electronic Property Problem
3
3
Unable to Obtain Readings
3
3
Application Program Version or Upgrade Problem
3
3
Human-Device Interface Problem
3
3
Device Markings/Labelling Problem
3
3
Device Handling Problem
3
3
Missing Test Results
3
3
Device Fell
3
3
Sharp Edges
2
2
Loss of Data
2
2
Detachment of Device or Device Component
2
2
Flare or Flash
2
2
Computer System Security Problem
2
2
Sparking
2
2
Problem with Software Installation
2
2
Device Contamination with Body Fluid
2
2
Circuit Failure
2
2
Failure to Back-Up
1
1
Contamination
1
1
Use of Incorrect Control/Treatment Settings
1
1
Crack
1
1
Degraded
1
1
Display or Visual Feedback Problem
1
1
Application Program Problem: Dose Calculation Error
1
1
Incorrect Measurement
1
1
Material Fragmentation
1
1
Melted
1
1
Unintended Collision
1
1
Unintended System Motion
1
1
No Device Output
1
1
Device Damaged Prior to Use
1
1
Low Readings
1
1
Failure to Align
1
1
Arcing
1
1
Defective Device
1
1
Application Program Problem: Parameter Calculation Error
1
1
Unstable
1
1
Failure to Read Input Signal
1
1
Protective Measures Problem
1
1
Temperature Problem
1
1
Unauthorized Access to Computer System
1
1
Mechanics Altered
1
1
Naturally Worn
1
1
Misassembly by Users
1
1
Power Problem
1
1
Application Program Problem: Medication Error
1
1
Application Network Problem
1
1
Data Back-Up Problem
1
1
Application Security Problem
1
1
Contamination /Decontamination Problem
1
1
Compatibility Problem
1
1
Device Ingredient or Reagent Problem
1
1
Device-Device Incompatibility
1
1
Unintended Electrical Shock
1
1
Excessive Heating
1
1
Program or Algorithm Execution Problem
1
1
Delayed Program or Algorithm Execution
1
1
Intermittent Program or Algorithm Execution
1
1
Program or Algorithm Execution Failure
1
1
Activation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
410
410
No Patient Involvement
196
196
No Known Impact Or Consequence To Patient
54
55
No Consequences Or Impact To Patient
52
52
Insufficient Information
37
37
Laceration(s)
8
8
Bone Fracture(s)
3
3
No Code Available
3
3
Abrasion
2
2
Arrhythmia
1
1
Exposure to Body Fluids
1
1
Erosion
1
1
Bruise/Contusion
1
1
Congenital Defect/Deformity
1
1
Cardiac Enzyme Elevation
1
1
Head Injury
1
1
Headache
1
1
Unspecified Infection
1
1
Neonatal Deformities
1
1
Sepsis
1
1
Skin Erosion
1
1
Therapeutic Effects, Unexpected
1
1
Concussion
1
1
Electrolyte Imbalance
1
1
Heart Failure
1
1
Viral Infection
1
1
Neck Pain
1
1
Missing Value Reason
1
1
Cancer
1
1
Unspecified Heart Problem
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Muscle/Tendon Damage
1
1
Partial thickness (Second Degree) Burn
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Laboratories, Inc
II
Sep-26-2019
2
Beckman Coulter Inc.
II
Aug-23-2021
3
Beckman Coulter Inc.
II
Nov-18-2019
4
Beckman Coulter Inc.
II
Jul-17-2019
5
Beckman Coulter, Inc.
II
Aug-11-2021
6
Becton Dickinson & Co.
II
Jul-06-2023
7
Becton Dickinson & Co.
II
Apr-29-2022
8
Becton Dickinson & Co.
II
Mar-23-2019
9
Inpeco S.A.
II
May-28-2020
10
Inpeco S.A.
II
May-26-2020
11
Normand-Info S.A.S.U.
II
Jun-08-2021
12
Normand-Info S.A.S.U.
II
Jul-31-2020
13
Normand-Info S.A.S.U.
II
Mar-03-2020
14
Roche Diabetes Care, Inc.
II
Apr-26-2022
15
Roche Diagnostics Corporation
III
Jul-03-2019
16
Roche Diagnostics Corporation
II
May-17-2019
17
Roche Diagnostics Operations, Inc.
II
Jan-12-2023
18
Roche Diagnostics Operations, Inc.
II
Sep-10-2021
19
Roche Diagnostics Operations, Inc.
II
Jan-22-2021
20
Roche Diagnostics Operations, Inc.
II
Nov-17-2020
21
Roche Diagnostics Operations, Inc.
II
Feb-12-2020
22
Roche Diagnostics Operations, Inc.
II
Jan-30-2020
23
Siemens Healthcare Diagnostics, Inc.
II
Apr-18-2019
24
Soft Computer Consultants, Inc.
II
Jul-20-2021
25
Soft Computer Consultants, Inc.
II
Jul-19-2021
26
Technidata S.A.
II
May-10-2023
-
-