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 2018-01-29 for ADVIA CENTAUR XPT PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY N/A 10310292 manufactured by Siemens Healthcare Diagnotics, Inc.
[105522500]
The procedural notes high-dose hook effect section of the instructions for use (ifu) states the following: "patient samples with high total psa levels can cause a paradoxical decrease in the rlus (high-dose hook effect). In this assay, patient samples with total psa levels as high as 10,000 ng/ml (10,000 ug/l) will assay greater than 100 ng/ml (100 ug/l). " given that the diluted value of the sample is 11, 495 ng/ml which is greater than 10,000 ng/ml stated in the ifu, the assay is performing as intended. Additionally, siemens issued urgent field corrective action cc 16-05. A. Ous and urgent medical device correction cc 16-05. A. Us in december 2015 informing the customer that the advia centaur systems prostate specific antigen (psa) assay kit lots ending in 263 and above are not meeting the current high-dose hook effect expectation in the instructions for use (ifu). Instructions on actions to be taken are provided in the customer communication. The communication states, "based on siemens' internal testing, samples with total psa concentrations between 4200 ng/ml (ug/l) and 8400 ng/ml (ug/l) do not assay >100 ng/ml (ug/l) but instead result in falsely depressed concentrations of approximately 50 ng/ml (ug/l) to 94 ng/ml (ug/l). " siemens has requested the sample for research and development to use in their studies for these communications. The intended use section of the ifu states the following: "this in vitro diagnostic assay is intended to quantitatively measure prostate-specific antigen (psa) in human serum using the advia centaur and advia centaur xp 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 limitation section of the ifu 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. "
Patient Sequence No: 1, Text Type: N, H10
[105522501]
Customer observed an advia centaur xpt prostate specific antigen (psa) result from a sample which was depressed when tested neat compared to the results from dilution of the sample and to an alternate method. There are no reports that treatment was altered or prescribed or adverse health consequences due to the depressed advia centaur xpt psa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219913-2018-00129 |
| MDR Report Key | 7426528 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-29 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2017-08-03 |
| Date Added to Maude | 2018-04-12 |
| 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 | LOUISE MCLAUGHLIN |
| Manufacturer Street | 333 CONEY STREET |
| Manufacturer City | EAST WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604381 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 1219913-12/30/2015-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XPT PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY |
| Generic Name | PSA IMMUNOASSAY |
| Product Code | MTF |
| Date Received | 2018-01-29 |
| Model Number | N/A |
| Catalog Number | 10310292 |
| Lot Number | 42347282 |
| Device Expiration Date | 2018-08-03 |
| 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 DIAGNOTICS, INC |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 105915097 US 105915097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-29 |