On (b)(6) 2020, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result of 3.6 on a (b)(6) year old male patient.There was no additional patient information available at the time of this report.Return product is available for investigation.Method: i-stat, date: (b)(6) 2020, collected: 0829, tested: immediately, result: 3.6 inr, sample: wb.Lab, (b)(6) 2020, 0712, ni, 5.1 inr, plasma.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on limited information available that suggests the product was not performing within the variability of the assay.The facility stated that the patient was scheduled for another test on (b)(6) 2020 but the results of the test was not provided.Apoc has asked if the lab result was questioned since it was tested before i-stat.There were multiple attempts to obtain information but to no avail.The investigation is underway.
|