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TPLC
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Device
test, time, prothrombin
Product Code
GJS
Regulation Number
864.7750
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
1
ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE
SE - WITH LIMITATIONS
1
BIOSITE INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
COAGUSENSE, INC
SUBSTANTIALLY EQUIVALENT
1
COAGUSENSE, INC.
SUBSTANTIALLY EQUIVALENT
2
DIAGNOSTICA STAGO SAS
SUBSTANTIALLY EQUIVALENT
1
ILINE MICROSYSTEMS S.L.
SUBSTANTIALLY EQUIVALENT
3
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
3
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
4
ROCHE DIAGNOSTICS CORP.
SUBSTANTIALLY EQUIVALENT
1
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
UNIVERSAL BIOSENSORS PTY LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2397
2397
2015
1260
1260
2016
864
864
2017
532
532
2018
1958
1958
2019
2385
2385
2020
1390
1390
2021
1359
1359
2022
1210
1210
2023
809
809
2024
36
36
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
6680
6680
Incorrect Or Inadequate Test Results
2561
2561
Incorrect, Inadequate or Imprecise Result or Readings
2289
2289
Low Test Results
1426
1426
Non Reproducible Results
849
849
Image Display Error/Artifact
394
394
Display Difficult to Read
180
180
Adverse Event Without Identified Device or Use Problem
112
112
Improper or Incorrect Procedure or Method
103
103
Circuit Failure
91
91
Nonstandard Device
87
87
Incorrect Measurement
77
77
Display or Visual Feedback Problem
59
59
Device Difficult to Setup or Prepare
41
41
No Device Output
34
34
High Readings
29
29
No Display/Image
28
28
Device Displays Incorrect Message
27
27
Insufficient Information
22
22
Lack of Maintenance Documentation or Guidelines
16
16
Device Operates Differently Than Expected
14
14
Device Issue
12
12
Low Readings
11
11
Appropriate Term/Code Not Available
11
11
Unauthorized Access to Computer System
10
10
Use of Device Problem
10
10
Erratic or Intermittent Display
10
10
Thermal Decomposition of Device
9
9
Unexpected Therapeutic Results
9
9
Device Handling Problem
9
9
Melted
8
8
Calibration Problem
7
7
Improper Device Output
7
7
Output Problem
7
7
Human-Device Interface Problem
6
6
No Apparent Adverse Event
6
6
Defective Device
6
6
Defective Component
6
6
False Reading From Device Non-Compliance
6
6
Off-Label Use
6
6
Device Expiration Issue
6
6
False Positive Result
5
5
Failure to Power Up
5
5
Imprecision
5
5
Mechanical Problem
5
5
Unable to Obtain Readings
5
5
Device Markings/Labelling Problem
5
5
Patient Data Problem
4
4
Shelf Life Exceeded
4
4
Smoking
4
4
Electrical /Electronic Property Problem
4
4
Use of Incorrect Control/Treatment Settings
4
4
Contamination
3
3
Product Quality Problem
3
3
Failure to Read Input Signal
3
3
Battery Problem
3
3
Loss of Data
3
3
Date/Time-Related Software Problem
3
3
Misassembly by Users
3
3
Inaccurate Information
3
3
Device Sensing Problem
3
3
Device Contamination with Chemical or Other Material
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Human Factors Issue
2
2
Audible Prompt/Feedback Problem
2
2
Data Problem
2
2
Expiration Date Error
2
2
Failure to Transmit Record
2
2
Inadequate or Insufficient Training
2
2
Poor Quality Image
2
2
Labelling, Instructions for Use or Training Problem
2
2
Computer Software Problem
2
2
False Negative Result
2
2
Application Program Problem: Dose Calculation Error
1
1
Corroded
1
1
Crack
1
1
Material Discolored
1
1
Filling Problem
1
1
Overheating of Device
1
1
Occlusion Within Device
1
1
Unintended Collision
1
1
Device Stops Intermittently
1
1
Tear, Rip or Hole in Device Packaging
1
1
Overfill
1
1
Failure to Calibrate
1
1
Inadequate Service
1
1
Inadequacy of Device Shape and/or Size
1
1
Shipping Damage or Problem
1
1
Application Program Problem
1
1
Structural Problem
1
1
Missing Test Results
1
1
Unclear Information
1
1
Activation Problem
1
1
Fail-Safe Problem
1
1
Compatibility Problem
1
1
Material Integrity Problem
1
1
Material Twisted/Bent
1
1
Power Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
8694
8695
No Clinical Signs, Symptoms or Conditions
3044
3044
No Known Impact Or Consequence To Patient
1724
1724
Coagulation Disorder
174
174
Hemorrhage/Bleeding
141
141
No Information
128
128
No Code Available
114
114
Insufficient Information
93
93
Stroke/CVA
61
61
Test Result
59
59
Death
50
50
Transient Ischemic Attack
33
33
Bruise/Contusion
31
31
Hematuria
29
29
Patient Problem/Medical Problem
27
27
Thrombosis
25
25
Misdiagnosis
25
25
Pain
22
22
Thrombosis/Thrombus
20
20
Thrombus
19
19
Ischemia Stroke
17
17
Atrial Fibrillation
16
16
Anemia
16
16
Fall
15
15
Hematoma
15
15
Complaint, Ill-Defined
15
15
Dizziness
14
14
No Patient Involvement
14
14
Thromboembolism
14
14
Pneumonia
14
14
Chest Pain
13
13
Dyspnea
12
12
Weakness
12
12
Swelling
11
11
Pulmonary Embolism
11
11
Overdose
11
11
Unspecified Infection
10
10
Headache
10
10
Intracranial Hemorrhage
8
8
High Blood Pressure/ Hypertension
8
8
Myocardial Infarction
8
8
Hemorrhagic Stroke
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
7
7
Gastrointestinal Hemorrhage
7
7
Speech Disorder
6
6
Abdominal Pain
6
6
Urinary Tract Infection
6
6
Vomiting
6
6
Confusion/ Disorientation
6
6
Blood Loss
5
5
Ambulation Difficulties
5
5
Toxicity
5
5
Numbness
5
5
Nausea
5
5
Renal Failure
5
5
Inflammation
4
4
Ischemia
4
4
Low Blood Pressure/ Hypotension
4
4
Cardiac Arrest
4
4
Embolism
4
4
Chills
4
4
Skin Discoloration
4
4
Sepsis
3
3
Dysphasia
3
3
Ulcer
3
3
Anxiety
3
3
Respiratory Failure
3
3
Lethargy
3
3
Loss of consciousness
3
3
Balance Problems
3
3
Cancer
3
3
Cardiac Enzyme Elevation
3
3
Bronchitis
3
3
Angina
3
3
Apnea
3
3
Hemorrhage, Subdural
3
3
Fever
3
3
Hemoptysis
3
3
Respiratory Distress
3
3
Paralysis
3
3
Paresis
2
2
Seizures
2
2
Laceration(s)
2
2
Hemorrhage, Cerebral
2
2
Bone Fracture(s)
2
2
Head Injury
2
2
Bacterial Infection
2
2
Erythema
2
2
Dehydration
2
2
Diarrhea
2
2
Infarction, Cerebral
2
2
Congestive Heart Failure
2
2
Lymphoma
2
2
Underdose
2
2
Valvular Stenosis
2
2
Cognitive Changes
2
2
Injury
2
2
Malaise
2
2
Heart Failure
2
2
Brain Injury
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Point Of Care Inc.
II
Aug-10-2015
2
Abbott Point Of Care Inc.
II
Dec-04-2013
3
Abbott Point Of Care Inc.
II
Aug-08-2012
4
Abbott Point of Care Inc.
II
Jul-13-2010
5
Alere San Diego
II
Jun-24-2011
6
Alere San Diego, Inc.
I
Aug-19-2016
7
Alere San Diego, Inc.
I
Jan-03-2015
8
Alere San Diego, Inc.
I
May-08-2014
9
Assuramed
II
Sep-13-2013
10
Diagnostica Stago, Inc.
II
Sep-07-2018
11
Diagnostica Stago, Inc.
II
Mar-15-2018
12
Fisher Diagnostics, A Company of Fisher Scientific LLC
II
Jun-26-2015
13
HemoSense Inc
III
May-22-2009
14
Instrumentation Laboratory
II
May-10-2022
15
Instrumentation Laboratory
II
Nov-23-2021
16
Instrumentation Laboratory Co.
II
Oct-05-2018
17
Instrumentation Laboratory Co.
II
Mar-03-2018
18
Instrumentation Laboratory Co.
II
Dec-19-2014
19
Instrumentation Laboratory Co.
II
Jul-22-2013
20
International Technidyne Corp.
II
Feb-19-2013
21
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
22
Roche Diagnostics Corp.
II
Aug-11-2009
23
Roche Diagnostics Corporation
I
Nov-02-2018
24
Roche Diagnostics Operations, Inc.
II
Jan-07-2021
25
Roche Diagnostics Operations, Inc.
II
Jun-24-2013
26
Roche Diagnostics Operations, Inc.
II
Apr-15-2013
27
Roche Diagnostics Operations, inc.
II
Sep-03-2009
28
TERRIFIC CARE LLC
I
Feb-01-2019
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