Mayo patients received inaccurate prostate results due to faulty equipment

The statement continued: “It is important to note that this testing is a first step to diagnosis. The National Prostate Cancer GP referral guidelines state that patients with an abnormal PSA result should have a repeat PSA at six weeks. A clinical prostate assessment to include a digital rectal examination and the second PSA test is therefore undertaken prior to biopsy in order to confirm the diagnosis and initiate treatment if required.”

The testing kits have been the subject of an international field safety notice but upon receipt of the notice on July 1 this year the biochemistry department at Mayo General Hospital immediately ceased PSA testing using the Siemens product and transferred to the Roche Cobas E411 platform.

Mayo General Hospital attached a comment to all new PSA results informing doctors that a new method was now being used for PSA and alerted them to the positive bias in the previous tests.

In addition Mayo General Hospital has contacted all doctors who requested this test during those dates, advising them about the field notice and offering to re-test any patients (using the new Roche total PSA method ) about whom they have any concerns.

“Patients should wait to hear from their GP in the first instance and need not take any action. We expect the notifications to GPs and other referring doctors to be completed shortly,” the hospital has confirmed.

 

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