MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-07-05 for ADVIA CENTAUR XPT PSA ASSAY N/A 10310293 manufactured by Siemens Healthcare Diagnostics, Inc..
[119809018]
The cause for the falsely high advia centaur xpt prostate-specific antigen (psa) result is being investigating by siemens. The patient sample has been requested for further testing. The instruction for use (ifu) under the intended use section states the following: "this in vitro diagnostic assay is intended to quantitatively measure prostate-specific antigen (psa) in human serum using the advia centaur? , advia centaur xp, and advia centaur xpt systems. This assay is indicated for the measurement of serum psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years and older. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer. " the instruction for use (ifu under the summary and explanation section states the following: "psa levels increase in men with cancer of the prostate, and after radical prostatectomy psa levels routinely fall to the undetectable range. If prostatic tissue remains after surgery or metastasis has occurred, psa appears to be useful in detecting residual and early recurrence of tumor. Therefore, serial psa levels can help determine the success of prostatectomy, and the need for further treatment, such as radiation, endocrine or chemotherapy, and in the monitoring of the effectiveness of therapy. " the instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings. " the instruction for use (ifu) under the limitation section states the following: "warning" "do not predict disease recurrence solely on serial psa values. " "do not interpret levels of psa as absolute evidence of the presence or the absence of malignant disease. Before treatment, patients with confirmed prostate carcinoma frequently have levels of psa within the range observed in healthy individuals. Elevated levels of psa can be observed in patients with nonmalignant diseases. Measurements of psa should always be used in conjunction with other diagnostic procedures, including information from the patient's clinical evaluation. The concentration of total psa in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods, calibration, and reagent specificity. Total psa determined with different manufacturers' assays will vary depending on the method of standardization and antibody specificity. " mdr 1219913-2018-00151 was filed previously for a falsely elevated result on the same patient. Mdr 1219913-2018-00151 supplemental report 1 was filed for a result correction, and additional information. Mdr 1219913-2018-00151 supplemental report 2 for a correction, and patient/test information not originally provided.
Patient Sequence No: 1, Text Type: N, H10
[119809019]
A false high advia centaur xpt prostate-specific antigen (psa) result was obtained by the customer on a prostatectomy patient. The patient was redrawn due to a previous advia centaur xpt psa result ((b)(6) 2018) that was falsely elevated, and questioned by the physician. There are no reports that patient treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xpt psa result. Mdr 1219913-2018-00151 was filed previously for a falsely elevated result on the same patient. Mdr 1219913-2018-00151 supplemental report 1 was filed for a result correction, and additional information. Mdr 1219913-2018-00151 supplemental report 2 was filed for a correction and additional information that was not originally provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00219 |
| MDR Report Key | 7848476 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-05 |
| Date of Report | 2018-07-05 |
| Date of Event | 2018-06-11 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2018-09-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHEN PERRY |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XPT PSA ASSAY |
| Generic Name | PSA IMMUNOASSAY |
| Product Code | MTF |
| Date Received | 2018-07-05 |
| Model Number | N/A |
| Catalog Number | 10310293 |
| Lot Number | 032287 |
| Device Expiration Date | 2019-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-05 |