MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-03-06 for ADVIA CENTAUR XP 078-A010-XX manufactured by Siemens Healthcare Diagnostics, Inc..
[2395107]
Potentially erroneous, but believable enhanced human immunodeficiency virus (ehiv) patient results were generated on the advia centaur xp. It is unknown if patient results were reported to the physician(s). There are no known reports of adverse health consequences or patient intervention due to the potentially erroneous, but believable ehiv patient results.
Patient Sequence No: 1, Text Type: D, B5
[9607059]
A siemens technical service consultant (tsc) was contacted by the customer. After evaluation of the issue and data by the tsc, it was determined that the instrument was in fse (field service engineer) mode and the control bracketing option had been disabled. The operator re-enabled the control bracketing option and logged into the system at the customer level. The device is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00061 |
| MDR Report Key | 2480690 |
| Report Source | 05,06 |
| Date Received | 2012-03-06 |
| Date of Report | 2012-02-06 |
| Date of Event | 2012-01-23 |
| Date Mfgr Received | 2012-02-06 |
| Device Manufacturer Date | 2010-10-08 |
| Date Added to Maude | 2012-08-27 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LTD, CHAPEL LANE |
| Manufacturer City | 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 | NHS |
| Date Received | 2012-03-06 |
| Model Number | ADVIA CENTAUR XP |
| Catalog Number | 078-A010-XX |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | N |
| Device Age | 17 MO |
| 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 | 2012-03-06 |