MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-06 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[5825119]
The operator of an advia centaur xp instrument stated that discordant, falsely low results for multiple assays were obtained on patient samples. The discordant results were not reported to the physician(s). The samples were repeated on the same instrument and the operator stated that the results were as excepted upon repeat. It is unknown if the repeat results were reported the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low results.
Patient Sequence No: 1, Text Type: D, B5
[13385471]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and performed a total service call. The cse discovered that the instrument was intermittently dispensing fluids when fluids should not be dispensed, causing cuvettes to be over-filled. The cse repositioned and seated the re-suspend water lines. The cse also discovered that the incubation ring was falling into the original cuvette position instead of advancing and dispensing into the original cuvette again, overfilling it. The incubation ring was cleaned and a defective ring index pin and spring were replaced. The cse discovered a leak from a base fitting on the luminometer and tightened the fitting. The cse verified that the instrument was dispensing and aspirating within specifications. The cse ran quality controls, which were within acceptable ranges. The cause of the discordant results was related to the faulty index pin and re-suspend water lines. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00224 |
| MDR Report Key | 4753981 |
| Report Source | 05,06 |
| Date Received | 2015-05-06 |
| Date of Report | 2015-04-09 |
| Date of Event | 2015-04-09 |
| Date Mfgr Received | 2015-04-09 |
| Device Manufacturer Date | 2006-12-18 |
| Date Added to Maude | 2015-06-04 |
| 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 NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 CHAPEL LANE, SWORDS, CO., |
| Manufacturer City | 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 | 2015-05-06 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-05-06 |