Events

Safety Alert for PSA IMMULITE / IMMULITE 1000 and PSA IMMULITE 2000 - ANVISA Registry No. 10345160687 and 10345160915

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnostics Products Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1284
  • Date
    2013-08-12
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    Siemens healthcare diagnostics has confirmed an overall mean positive bias of approximately 20% - 23% across the entire test range compared to who 96/670 with the immulite assays. this positive bias is observed in patient values ​​and controls of siemens tumor marker (tmco). the positive bias reported begins in the kits lots launched in february 2012: • immulite / immulite 1000 kit lkps of lot 422 and lkpts of lot d103. • immulite 2000 / immulite 2000 xpi kit l2kps from lot 377 and l2kpts from lot d104.
  • Action
    Discontinue use and segregate the remaining kits from your inventory with a view to returning these products to Siemens. If you have purchased the affected product from an authorized distributor, please return the product to your dealer. Siemens will replace any unused inventory of affected lots at no cost. Please contact your local Siemens representative for assistance in determining the appropriate solution for your laboratory's PSA testing. In addition, please proceed as follows: • Complete and return the Effectiveness Check Form • Forward this letter to whom you may have distributed these products. If you have questions or need additional information, please contact the Customer Support Center (0800-129-633).

Device

PSA IMMULITE / IMMULITE 1000 and PSA IMMULITE 2000 - ANVISA Registry No. 10345160687 and 10345160915

Manufacturer

Siemens Healthcare Diagnostics Products Ltd
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA