MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-20 for ADVIA CENTAUR XP 078-A010 manufactured by Siemens Healthcare Diagnostics Inc..
[3196720]
A discordant phenobarbital result was obtained on one patient sample on an advia centaur xp instrument. The discordant phenobarbital result was reported to the physician, who questioned the result. The same sample was rerun on the same instrument and the corrected result was reported to the physician. There are no reports of patient intervention or adverse health consequences due to the discordant phenobarbital result.
Patient Sequence No: 1, Text Type: D, B5
[10542584]
A siemens field service engineer was dispatched to the customer site. The fse analyzed the instrument and determined the cause of the discordant phenobarbital result was unknown. The fse checked the probe to cuvette calibration and checked the sample and ancillary probes. The fse replaced a vertical guide rod on reagent probe 1 and successfully ran qc. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00092 |
| MDR Report Key | 3011955 |
| Report Source | 05,06 |
| Date Received | 2013-03-20 |
| Date of Report | 2013-02-19 |
| Date of Event | 2013-02-18 |
| Date Mfgr Received | 2013-02-19 |
| Device Manufacturer Date | 2008-02-06 |
| Date Added to Maude | 2013-05-21 |
| 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 | JOHN NELSON |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED CHAPEL LANE, SWORDS |
| 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 XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | DLZ |
| Date Received | 2013-03-20 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010 |
| 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 | 2013-03-20 |