MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-04-29 for ADVIA CENTAUR PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY N/A 02676506 manufactured by Siemens Healthcare Diagnostics, Inc..
[1850080]
A low advia centaur psa result was obtained on a patient sample and discordant when compared to the patient's previous psa test history. The customer performed repeat testing per laboratory policy and the test results were positive. The discordant low psa result was not reported. Patient treatment was not prescribed or altered. There was no report of adverse health consequences due to the low psa result.
Patient Sequence No: 1, Text Type: D, B5
[9042034]
The cause for the low psa result is unknown. The customer reviewed the event log and noted a reagent probe 1 volume check error in the psa reagent pack. A low volume psa reagent pack may have been a contributing factor. No conclusion can be drawn. The instrument is performing within specification. No further evaluation of the device is required. The ifu states in the limitations section: "note: 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 conjunctions 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. Warning: do not predict disease recurrence solely on serial psa values. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2011-00056 |
| MDR Report Key | 2072518 |
| Report Source | 05,06 |
| Date Received | 2011-04-29 |
| Date of Report | 2011-03-31 |
| Date of Event | 2011-03-31 |
| Date Mfgr Received | 2011-03-31 |
| Date Added to Maude | 2012-05-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. STEPHEN PERRY |
| Manufacturer Street | 333 CONEY ST. |
| 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 | 0 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR PROSTATE-SPECIFIC ANTIGEN (PSA) ASSAY |
| Generic Name | PSA IMMUNOASSAY |
| Product Code | NAF |
| Date Received | 2011-04-29 |
| Model Number | N/A |
| Catalog Number | 02676506 |
| Lot Number | 224 |
| Device Expiration Date | 2011-11-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-29 |