On (b)(6) 2020, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine result of 230 umol/l on a patient.The customer stated that 230 umol/l was unexpected as the patient had a normal egfr just a few weeks ago (approximately 80).There was no patient information available at the time of this report.Return product is not available for investigation.(b)(6).The same sample was tested on one of the cardiac ct i-stat 1 analyzer, as well as the ct i-stat, 1 analyzer from pathology.Once again both results came in around 220 umol/l.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The customer was advised that using a serum specimen is outside of the intended use (off-label) for the i-stat creatinine test.Reference: cartridge and test information (cti) art (b)(4).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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