On (b)(6) 2019, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine results on a female patient presented for a transcatheter aortic valve replacement (tavr) procedure.There was no additional patient information available at the time of this report.Return product is available for investigation.(b)(6).There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The i-stat results were consistent at with two different samples while the alternate method was consistent with its repeat on the same sample.There was no patient information or medications provided.It is suspected that the patient is on hydroxyurea, a substance that is known to interfere with the i-stat creatinine assay.However, this could not be confirmed at the time of this report.Refer to i-stat system manual, art: 714183-00 rev aa.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
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