MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-03 for ADVIA CENTAUR XP 078-A011-03 manufactured by Siemens Healthcare Diagnostics Inc..
[19721887]
A discordant, falsely low gentamycin result was obtained on one patient sample on an advia centaur xp instrument. The discordant result was reported to the pharmacy, who questioned it. A new aliquot and an original aliquot from the same tube were repeated on the same instrument, resulting higher. The corrected result was reported to the pharmacy. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low gentamycin result.
Patient Sequence No: 1, Text Type: D, B5
[19866526]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. The cse evaluated the instrument and discovered that the acid pump was crusted. The cse replaced the acid and the base pumps and performed a total service call. The cse calibrated the gentamycin and ipth assays and ran quality controls. The cause of the discordant, falsely low gentamycin result on one patient sample is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00168 |
| MDR Report Key | 4659078 |
| Report Source | 05,06 |
| Date Received | 2015-04-03 |
| Date of Report | 2015-03-10 |
| Date of Event | 2015-03-04 |
| Date Mfgr Received | 2015-03-10 |
| Device Manufacturer Date | 2011-06-27 |
| Date Added to Maude | 2015-05-06 |
| 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 | 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 REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, 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 | LCD |
| Date Received | 2015-04-03 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A011-03 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-03 |