It was alleged that a patient had two hematomas in the brain in (b)(6)2018 when using coaguchek xs meter serial number (b)(6).The specific date of the event is not known.The patient's doctors reportedly found 2 hematomas in the patient's brain in august 2018.The patient's inr before hospitalization and at the hospital are not known.The patient was reportedly testing once per month when the event occurred.The patient reportedly received a vitamin k injection and was on a heparin drip for surgery.The patient's doctors reportedly advised they did not know what caused the brain bleed, but the hematomas shifted the patient's brain 0.5 inches and the patient required surgery to have one hematoma removed.The patient's doctors reportedly advised that the other hematoma would dissolve on its own and it reportedly did dissolve.Upon discharge from the hospital, the patient was reportedly given heparin to take home to bridge and get her back within her therapeutic range.The patient's therapeutic range is reported as 2.5 - 3.5 inr.The patient's current interval of testing is reported to be weekly.This mdr is being submitted in an abundance of caution.
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