Alere INRatio Device Lawsuits
Patients on Warfarin anticoagulant blood thinner are filing Alere INRatio lawsuits because their Alere INRatio device and blood-testing strips are defective and not providing accurate readings of their blood clotting ability.
Injured by Alere Monitoring System? Call Dr Shezad Malik Law Firm
ARE YOU LOOKING FOR ALERE BRAIN BLEED OR GASTRO-INTESTINAL BLEEDING ATTORNEY?
As a result of the manufacturer's failure to adequately warn about the risks associated with the blood testing device, financial compensation may be available through an Alere lawsuit for individuals who have experienced:
- Internal Bleeding or Gastrointestinal Bleeding
- Brain Hemorrhage
- Intra-Cranial Bleed
- Intra-Cerebral Bleed
- Sub-Dural Hematoma
- Hemorrhagic Stroke
- Wrongful Death From Bleeding Problems
DR SHEZAD MALIK LAW FIRM CAN HELP-CALL US
The Dr Shezad Malik Law Firm is currently investigating and accepting Alere monitoring system device bleeding injury cases nationwide, including California, Florida, Illinois, New York and Texas.
We are accepting and evaluating Alere bleeding side effect cases including uncontrollable gastrointestinal bleeding (stomach, colon, rectum), brain bleeding (intracranial bleeding, intracerebral bleeding, sub-dural hematoma), uncontrollable bleeding from minor cuts/lacerations, slip and falls, minor trauma, bleeding episodes requiring hospitalizations, blood transfusions and death.
If you or somebody you know has been injured or died as a result of Alere bleeding, you should contact the Alere Injury Team attorneys at the Dr Malik Law Firm immediately for a free case consultation. Please use the contact form to contact us or call toll free 24 hours a day at (888) 210-9693 ext 2.
ALERE MONITORING SYSTEM HOME TESTING DEVICE
Some patients on warfarin choose to monitor their blood levels at home instead of at a lab, by using the Alere INRatio, INRatio2 PT/INR Monitor System, and INRatio Test Strips, known as the Alere INRatio Monitoring System. This device has been promoted to patients on blood thinners to provide at home monitoring of their international normalized ratio (INR).
The Alere INRatio Monitoring System, has been recalled and displays therapeutic or treatment range INR levels for patients when their INR levels are dangerously high (beyond the treatment range) when compared to testing that is performed in a laboratory.
In other words, the Alere INRatio Monitoring System is inaccurate. This inaccuracy of the INR can cause serious and deadly side effects, by the blood being too thin. An Alere INRatio lawsuit alleges that the manufacturer knew of this potential problem, but failed to timely inform the FDA, doctors and patients that the Alere INRatio Monitoring System should not be used by patients.
WHAT IS THE ALERE INRATIO MONITORING SYSTEM?
The Alere Home INR Monitoring System is a portable device that can be used at home for blood thinning management. Prior to this device, patients would have to go to a lab at least once a month or more frequently to check their INR. The device measures the time it takes for a patient’s blood to clot, and displays that information as an INR.
For most patients taking warfarin, an INR level of 2.0 to 3.0 provides an adequate blood thinning for the treatment blood clots or to prevent blood clots. Based on these readings, a doctor can adjust a patient’s dosage of warfarin.
Anticoagulants are used in patients who have:
- Heart valve surgery
- Atrial fibrillation a common heart rhythm problem
- Prevention and treatment of DVT (deep vein thrombosis or blood clots in the legs) and pulmonary embolisms (blood clots in the lungs).
WHAT IS THE PROBLEM WITH ALERE INRATIO MONITORING SYSTEM?
The Alere INRatio Monitoring System is not accurate to replace laboratory testing and Alere, the manufacturer, knew of this fact but failed to warn the public. The use of Alere INRatio Monitoring can result in significantly lower INR readings than those correctly analyzed through the gold standard laboratory plasma INR test.
Alere studies show that INR readings from Alere home INR monitoring can be between 3.1 to 12.2 units lower than laboratory results. According to the FDA’s safety alert, patients are at serious risk of suffering from bleeding side effects including deadly brain bleeds, strokes, gastrointestinal and rectal bleeding.
Alere, Inc. has received 18,924 reports of incidents where the INRatio Monitoring System malfunctioned.
ALERE INRATIO MONITORING SYSTEM RECALLS
On April 16, 2014, Alere recalled several Alere INRatio2 PT/INR Professional Test Strips manufactured from August 22, 2013 through April 2, 2014. Alere noted “nine serious adverse event reports, three of which described bleeding associated with patient deaths.”
On December 8, 2014, Alere Inc. issued an additional recall involving the Alere INRatio Monitor System.
THE INRATIO MONITORING DEVICES AFFECTED BY ALERE RECALL
According to the FDA, the following Alere INRatio devices have been recalled:
INRATIO TEST STRIPS
0100071 Alere INRatio PT/INR Test Strips, Box of 12
0100139 Alere INRatio PT/INR Test Strips, Box of 48
0100004 Alere INRatio PT/INR System Professional
0100007 INRatio Prothrombin Time (PT) Monitoring System
0200431 Alere INRatio2 PT/INR Professional Testing System
0200432 Alere INRatio PT/INR Home Monitoring System
55128A Alere INRatio PT/INR Professional Monitoring System
55130 Alere INRatio PT/INR Monitor
All of the affected devices were manufactured and distributed between April 1, 2008 and December 4, 2014
ALERE INRATIO NEWS
Alere Recall: INRatio and INRatio2 Provide False Results – July 12, 2016
FDA Receives Thousands of Reports on Alere INRatio Accuracy Issues – March 17, 2016
Headlines & Global News: Alere Test Strips, Monitor System Recalled by FDA – January 9, 2015
Forbes: ‘Urgent Product Recall For Patients On Blood Thinners’ – May 7, 2014
Reuters: ‘Alere Starts Urgent Recall of Some Blood Clot Test Strips’ – May 6, 2014
WHAT IS WARFARIN?
Warfarin is a blood thinner marketed under the brand names, Coumadin and Jantoven. It is important to monitor the PT/INR levels in order to manage a balance between blood clot prevention and severe bleeding events.
In the event that a patient’s PT/INR levels are higher than therapeutic levels, severe bruising or bleeding are possible. When this happens, an antidote must be given to reverse warfarin’s effects and stop the bleeding.