MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-08-22 for ADVIA CENTAUR XP 078-A011-03 manufactured by Siemens Healthcare Diagnostics, Inc..
[4841704]
A false negative advia centaur xp (b)(6) result was obtained on a patient sample. The (b)(6) result was considered discordant when repeat testing was performed by the customer on their alternate advia centaur xp instrument. The repeat test results from the same sample and another sample from the same patient, all resulted (b)(6). There was no report of patient intervention or adverse health consequences due to the discordant advia centaur xp (b)(6) assay result.
Patient Sequence No: 1, Text Type: D, B5
[12005235]
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 plunger, syringe, tubing from the probe tip to the dilutor and the ribbon cable from the transducer printed circuit board (pcb) to the global input output board (pcb). The cse adjusted the sample probe and rp3, decontaminated the acid and base reagents and replaced the sample/ancillary tower. The cause for the discordant (b)(6) result is unknown. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00476 |
| MDR Report Key | 4031805 |
| Report Source | 05,06 |
| Date Received | 2014-08-22 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-07-25 |
| Date Mfgr Received | 2014-07-28 |
| Device Manufacturer Date | 2010-03-15 |
| Date Added to Maude | 2014-09-08 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE, SWORDS, CO REGISTRATION NUMBER 8020888 |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | OBF |
| Date Received | 2014-08-22 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A011-03 |
| ID Number | N/A |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2014-08-22 |