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 6.1 on an (b)(6) year old male patient with drained bag with blood/bursting from recent hospitalization where patient was discharged on (b)(6) 2020.There was no additional patient information available at the time of this report.Return product is available for investigation.Method date collected tested inr pt sample cartridge lot #: i-stat (b)(6) 2020 12:07 12:07 6.1 67.4 fingerstick t20264a, lab (b)(6) 2020 12:42 14:54 3.87 39.6 venous drawn n/a, i-stat (b)(6) 2020 11:29 11:29 5.2 57.3 fingerstick t20300d, lab (b)(6) 2020 11:54 14:00 2.62 27.0 venous drawn n/a.On (b)(6) 2020 the customer called to report a new test on the same patient with another cartridge lot (t20300d) seen as an outpatient.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 investigation is underway.
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