On (b)(6) 2024, abbott point of care (apoc) was contacted by a customer regarding i-stat b-hcg cartridges that yielded a positive result on a 18 year old female patient with abdominal pain, decreased appetite, nausea, vomiting, dysuria.There was no additional patient information at the time of this report.Return product is not available for investigation.Method date collected tested result i-stat on (b)(6) 2021 09:56am 10:08am 25.1 iu/ml roche on (b)(6) 2021 (b)(6) <5.0 iu/ml there are no injuries associated with this event.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.I-stat positive cut-off values: b-hcg < 5.0 iu/l negative 5.0 < ss-hcg < 25.0 iu/l indeterminate b-hcg >25.0 iu/l positive intended use: the i-stat® total beta-human chorionic gonadotropin (b-hcg) test is an in vitro diagnostic test for the quantitative and qualitative determination of b-hcg in venous whole blood or plasma samples using the i-stat 1 analyzer systems.The test is intended to be used as an aid in the early detection of pregnancy and is for prescription use only.
|