MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-20 for ADVIA CENTAUR XP 078-A011-03 manufactured by Siemens Healthcare Diagnostics Inc..
[5594076]
Discordant results were obtained on patient samples tested for multiple methods on an advia centaur xp instrument. The customer stated that half the samples were flagged by the instrument with sample integrity errors. It is unknown if discordant results were reported to the physician(s). It is unknown if repeat testing was performed and if corrected reports were sent out. There are no reports of patient intervention or adverse health consequences due to the discordant results.
Patient Sequence No: 1, Text Type: D, B5
[13101540]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse found clumpy reagents and a centaur water bottle next to the advia centaur system that was filled with contaminated fluid. The cse asked the customer not to use the system water bottles for waste or any other fluids except deionized water or cleaning solution and to use their reagent grade deionized water containers to fill the system water bottle until the quality of their deionized tap water could be verified. The cse also discovered that the refrigerator that is being used to store the centaur reagents is in a hallway next to a cold garage, and the refrigerator's temperature is not being monitored for the daily minimum and maximum temperatures. The cse discussed the issue with the customer and two digital thermometers were installed in the refrigerator. The cse replaced the luminometer. The customer calibrated all assays and ran quality controls. The customer performed a precision study on thyroid stimulating hormone (tsh), which resulted as expected. Upon follow up, the customer stated the instrument is performing without issues. The cause of the discordant results 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 | 2432235-2015-00133 |
| MDR Report Key | 4619531 |
| Report Source | 05,06 |
| Date Received | 2015-03-20 |
| Date of Report | 2015-02-26 |
| Date of Event | 2015-02-26 |
| Date Mfgr Received | 2015-02-26 |
| Device Manufacturer Date | 2011-05-23 |
| Date Added to Maude | 2015-04-22 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN 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, 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 | MOI |
| Date Received | 2015-03-20 |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-20 |