On (b)(6) 2018, abbott point of care (apoc) was contacted by a customer regarding i-stat crea+ cartridges that yielded a suspected discrepant creatinine result on a patient.There was no patient information available at the time of this report.Return product is not available.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.Apoc suspects that the high results are because the use of hydroxyurea.However this is not confirmed at this time.The customer states that they do not have visibility to that information and they have provided all the information that they are able to.Per i-stat system manual, art: 714183-00y.Rev.Date: 15-jul-16: hydroxyurea is a dna synthesis inhibitor used in the treatment of various forms of cancer, sickle cell anemia, and hiv infection.This drug is used to treat malignancies including melanoma, metastatic ovarian cancer, and chronic myelogenous leukemia.It is also used in the treatment of polycythemia vera, thrombocythemia, and psoriasis.At typical doses ranging from 500 mg to 2 g/day, concentrations of hydroxyurea in patients' blood may be sustained at approximately 100 to 500 [?]mol/l.Higher concentrations may be observed soon after dosing or at higher therapeutic doses.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
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