Alerta De Seguridad para PSA IMMULITE / IMMULITE 1000 and PSA IMMULITE 2000 - ANVISA Registry No. 10345160687 and 10345160915

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

A positive bias in PSA results may impact clinical interpretations of test results. In cases where true values ​​are close to cut, bias may increase the likelihood of a decision to initiate complementary diagnostic tests (including prostate biopsy). The risk of unnecessary biopsy is mitigated by the fact that the physician / patient decision for prostate biopsy is based on a number of additional factors for the PSA outcome, including the patient's age, findings in digital rectal examinations, clinical signs and symptoms or comorbidities such as inflammation or prostate infection. Total PSA is used in conjunction with a digital rectal examination to assist in determining if the patient is at risk for prostate cancer. The combination of the test result and an abnormal DRE may lead to a prostate biopsy. Sequential testing and a substantial change in results between tests may also raise the suspicion that the patient may be at risk for prostate cancer. When used in conjunction with the IMMULITE free PSA assay, bias would also result in a potentially lower than expected rate. Decreased indices are associated with increased risk of prostate cancer and could probably influence biopsy decisions. Findings in the biopsy are independent of the positive bias and health risk does not extend beyond biopsy and anxiety to the patient. The frequency of events of an increased value above the reference range of 4 is estimated at 5% (source not found) and having a positive DRE is estimated at 5% of the screened population equaling 2.5 x 10-3 in the worst case, very probably one tenth of this if the doctor questions the result. The health risk of an unnecessary biopsy is low.