On (b)(6) 2020 a patient having abdominal pain and vomiting.Arrived at the er needing radiology testing.A serum sample was taken, centifuged and applied to a fisher-sure-vue hcg stat serum/urine test with a false positive result.On an unknown date, the same sample was used for confirmatory testing with a siemens vista analyzer.The results were, <.0 1miu/ml, 1-3 is reference range for nonpregnant females.There was no adverse event, no treatment, procedure, or medications delayed or provided based on the alleged false positive result.
|
Investigation conclusion: the case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.Retained devices from the reported lot number were tested with hcg-negative clinical serum samples.The results were read at 5 and 6 minutes and all devices yielded the expected negative results.No false positive results were observed during in-house testing.Quantitative hcg analysis of the two patient serum samples provided found that the hcg concentrations were >1,000 miu/ml and 610.6 miu/ml.The sure-vue serum/urine hcg-stat has a sensitivity of 10 miu/ml in serum, therefore the positive results reported by the customer when testing these samples are accurate.The product performed as expected.
|