MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-02 for ADVIA CENTAUR CPSA ASSAY N/A 06684007 manufactured by Siemens Healthcare Diagnostics, Inc..
[3146536]
Falsely high advia centaur cpsa test results were obtained on a patient sample and considered discordant when compared to the biopsy results. There was no report of patient treatment being prescribed or altered and there was no report of adverse health consequences due to the discordant advia centaur cpsa result.
Patient Sequence No: 1, Text Type: D, B5
[10497348]
The cause for the discordant advia centaur cpsa result is unknown. The patient has high rheumatoid factors that may have influenced the cpsa assay. 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 conjunction with other diagnostic procedures, including information from the patient's clinical evaluation". "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays. "
Patient Sequence No: 1, Text Type: N, H10
[10629237]
Siemens filed the initial mdr 1219913-2012-00432 on (b)(4) 2013. Siemens filed the mdr 1219913-2012-00432 supplemental report #1 on (b)(4) 2013. (b)(4) 2013: additional information: the patient sample was tested by siemens healthcare diagnostics, as reported in supplemental 1219913-2012-00432 report #1. No conclusion can be drawn as the internal test results were elevated as initially observed by the customer. The indication is that the discordant patient results may be sample specific related. There have been no further reports of falsely elevated advia centaur cpsa results. Correction: the initial mdr had the box "[x] congenital anomaly/birth defect" checked by mistake. There was no congenital anomaly/birth defect attributed with this event. The statement "there was no report of patient treatment being prescribed or altered and there was no report of adverse health consequences due to the discordant advia centaur cpsa result" is correct.
Patient Sequence No: 1, Text Type: N, H10
[22321891]
Siemens filed the initial mdr 1219913-2012-00432 on (b)(4) 2013. (b)(4) 2013: additional information:the customer initially stated that it was unknown if a report was sent to the fda. The customer has confirmed that a report was not filed with the fda. The patient's sample was tested by siemens and the results are as follows:siemens patient sample test data: test results reagent lot # calibrator lot #cpsa 61. 85 ng/ml 244 y53psa 69. 15 ng/ml 244 q54fpsa 2. 74 ng/ml 15 c2508 psa 1:2 dilution 1:5 dilution 1:10 dilution 70. 07 ng/ml 69. 50 ng/ml 64. 76 ng/ml psa alternate method result: 92. 9 ng/ml (high result). Correction: the repeat sample test result of ~60 had been treated with heterophilic blocking tube (hbt).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219913-2012-00432 |
| MDR Report Key | 2893661 |
| Report Source | 05,06 |
| Date Received | 2013-01-02 |
| Date of Report | 2012-12-07 |
| Date of Event | 2012-12-07 |
| Date Mfgr Received | 2013-03-04 |
| Date Added to Maude | 2013-03-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. 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 | WALPOLE MA 02032 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02032 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR CPSA ASSAY |
| Generic Name | CPSA IMMUNOASSAY |
| Product Code | NAF |
| Date Received | 2013-01-02 |
| Model Number | N/A |
| Catalog Number | 06684007 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Congenital Not Applicablenomaly | 2013-01-02 |