The representative from alere reported on (b)(6) 2015 that the patient received an error 7 on the coaguchek xs system.The caller was advised that the reported error 7 is a measurement error caused by the blood sample and it could mean an inr result that is higher than the meter measuring range (highest reading is 8.0 inr) which would indicate a long coagulation time.The alere representative was told that an alternative test method should be sought.The alere representative acknowledged this information and stated they will have her tested in another way.Another alere representative called on (b)(6) 2015 and reported that the patient passed away that morning.The patient's daughter was contacted and stated her mom went to the hospital on (b)(6) 2015 and was admitted to the hospital due to internal bleeding.The patient did not receive medical treatment; she was transferred to hospice service because she was a do not resuscitate (dnr) patient, and passed away on (b)(6) 2015.No information regarding if or why not any lab result was sought on (b)(6) 2015.Her therapeutic range was 2.0 inr to 3.0 inr.Requested return of suspect system and replacement was sent.
|