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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, time, prothrombin
Product CodeGJS
Regulation Number 864.7750
Device Class 2


Premarket Reviews
ManufacturerDecision
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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