MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-30 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[24655439]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse found the serum buildup at the sample port and the ancillary reagent buildup at the ancillary entry port for the cuvette. The cse cleaned and replaced the sample syringe, the ancillary probe and the sleeve. The cse also found the buildup inside of a waste container. The cse cleaned and replaced the reservoir cap and fitting for the position. The cse ran precision testing, daily cleaning procedure and quality controls, all of which were acceptable. The cause of the discordant, false negative hcv 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
[24655440]
A discordant, false negative (b)(6) result was obtained on one patient sample on an advia centaur xp instrument. The discordant result was reported to the physician(s), who questioned it. The sample was tested using polymerase chain reaction, resulting positive. The same sample from different tube was repeated three times on the same instrument, all resulting positive. The corrected results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, false negative hcv result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2015-00339 |
| MDR Report Key | 4952326 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-07 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-07-07 |
| Device Manufacturer Date | 2009-10-05 |
| Date Added to Maude | 2015-07-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED REGISTRATION NUMBER: 8020888 |
| Manufacturer City | CHAPEL LANE, SWORDS, DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | OBF |
| Date Received | 2015-07-30 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| 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 | 2015-07-30 |