On 14-feb-2024, abbott point of care (apoc) was contacted by a customer regarding i-stat troponin cartridges that yielded a false positive result of 0.38 on a 65 year old female patient with left shoulder pain.Mi ruled out.There was no additional patient information at the time of this report.Return product is available for investigation.Method; date; collected; tested; result; sample.I-stat, (b)(6) 2024, 15:08, 15:09 , 0.38 ng/ml & a.I-stat, (b)(6) 2024, 15:08, ni, 0.00 ng/ml & a.I-stat, (b)(6) 2024, 17:38, 17:56, 0.00 ng/ml & b.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggested that product was not performing within the variability.There is no evidence the pateint suffered an mi.The investigation is underway.Per i-stat system manual: art: 715595-00v.Reportable range: 0.00 - 50.00.Reference range: 0.00 - 0.03 (represents the 0 to 97.5% range of results).Reference range: 0.00 - 0.08 (represents the 0 to 99% range of results).
|