MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-05 for ADVIA CENTAUR 078-A001-08 manufactured by Siemens Healthcare Diagnostics, Inc.
[5554625]
A discordant advia centaur testosterone (tsto) patient result was initially reported to siemens. The discordant result was questioned by the physician and the same patient sample was repeated and the result was lower. Another testosterone (tsto) patient result was repeated and the result was lower. The customer performed repeat testing on approximately 239 patient results that had been reported to the physician(s) on multiple advia centaur assays and informed siemens that there were additional discordant patient results. Corrected reports were issued to the physician(s). There was no report of patient intervention or adverse health consequences due to the discordant results obtained on multiple methods on an advia centaur instrument.
Patient Sequence No: 1, Text Type: D, B5
[13025852]
A siemens customer service engineer (cse) was sent to the customer site for instrument inspection. After evaluation of the instrument and instrument data, the cse replaced the sample syringe, and ran multiple test sample replicates. The results were repeatable and correlated with the customer's alternate analyzer. The cause of the discordant results obtained on multiple methods was the sample syringe malfunction. The instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00104 |
| MDR Report Key | 4573754 |
| Report Source | 05,06 |
| Date Received | 2015-03-05 |
| Date of Report | 2015-02-08 |
| Date of Event | 2015-02-04 |
| Date Mfgr Received | 2015-02-08 |
| Device Manufacturer Date | 2005-12-05 |
| Date Added to Maude | 2015-04-06 |
| 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 02032 |
| Manufacturer Country | US |
| Manufacturer Postal | 02032 |
| Manufacturer Phone | 5086604163 |
| Manufacturer G1 | SIEMENS HALTHCARE DIAGNOSTICS |
| Manufacturer Street | CHAPEL LANE, SWORDS REGISTRATION NUMBER 8020888 |
| Manufacturer City | CO. DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | CDZ |
| Date Received | 2015-03-05 |
| Model Number | ADVIA CENTAUR |
| Catalog Number | 078-A001-08 |
| ID Number | N/A |
| 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 | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-05 |