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 2014-05-05 for ADVIA CENTAUR XP 078-A010 manufactured by Siemens Healthcare Diagnostics Inc..
[22000929]
A discordant, false negative c human immunovirus (chiv) result was obtained on one patient sample on an advia centaur xp instrument. The discordant chiv result was reported to the physician(s). The sample was repeated four times on an alternate instrument. It is unknown what repeat results were reported to the physician(s). There were no reports of adverse health consequences or known patient intervention due to the discordant chiv results.
Patient Sequence No: 1, Text Type: D, B5
[22345739]
A siemens customer service engineer (cse) was dispatched to the customer site to evaluate the instrument and instrument data. The cse discovered reagent probe 1 displayed system errors when commencing fault finding for the chiv assay problem. The cse removed the reagent probe 1 assembly and cleaned the in-out optical sensor array. The cse also replaced a faulty separation manifold and performed a total service call on the instrument. The cse was involved with extensive troubleshooting, which required multiple customer site visits. The cause of the discordant chiv result is unknown. The cse successfully ran calibrations and 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 | 2432235-2014-00321 |
| MDR Report Key | 3791496 |
| Report Source | 01,05,06 |
| Date Received | 2014-05-05 |
| Date of Report | 2014-04-10 |
| Date of Event | 2014-03-11 |
| Date Mfgr Received | 2014-04-10 |
| Device Manufacturer Date | 2013-04-19 |
| Date Added to Maude | 2014-06-23 |
| 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 | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 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 | NHS |
| Date Received | 2014-05-05 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| 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 | 2014-05-05 |