MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-01-31 for ADVIA CENTAUR XP 078-A010-XX manufactured by Siemens Healthcare Diagnostics, Inc..
[3280970]
A discordant alpha fetoprotein (afp) result was generated by the advia centaur xp system. The initial result was not reported out of the laboratory. The sample was diluted and retested. The initial sample was also tested on an alternate system and yielded a high result. This sample was subsequently diluted and tested in 5 replicates. It is not known if any retest results were released. There were no reports of adverse health consequences or known patient intervention due to the discordant afp result.
Patient Sequence No: 1, Text Type: D, B5
[10473654]
A siemens field service engineer (fse) was sent to the customer site. After analyzing the instrument and data, the fse determined that the cause of the discordant alpha fetoprotein result was related to a misalignment. The fse adjusted the sample probe normal and dilution cuvette bottom calibration. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00037 |
| MDR Report Key | 2938500 |
| Report Source | 01,05,06 |
| Date Received | 2013-01-31 |
| Date of Report | 2013-01-09 |
| Date of Event | 2013-01-09 |
| Date Mfgr Received | 2013-01-09 |
| Device Manufacturer Date | 2007-01-29 |
| Date Added to Maude | 2013-04-17 |
| 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. MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED CHAPEL LANE, SWORDS |
| Manufacturer City | CO. DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code | NSF |
| Date Received | 2013-01-31 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010-XX |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER HEALTH CARE 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 | 2013-01-31 |