MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-11-01 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[58851447]
The customer contacted a siemens customer care center (ccc) specialist and stated that their quality controls were out of ranges. A siemens customer service engineer (cse) specialist was dispatched to the customer site. The cse evaluated the instrument and performed a total service call. The cse inspected the probes, checked the calibrations and dispenses and replaced the reagent probe 1. The cse then inspected and cleaned the wash stations, checked the port dispenses and replaced the aspirate wash guides. The cse also cleaned the aspirate and water lines with bleach, inspected the fittings of the manifolds, diluters, pumps and tubings and ran quality controls, which were acceptable. The cause of the discordant, falsely elevated ferritin 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
[58851448]
A discordant, falsely elevated ferritin (ferr) result was obtained on one patient sample upon repeat testing on an advia centaur xp instrument. The sample was initially run on the same instrument, resulting lower. The initial and repeat results were not reported to the physician(s). The sample was repeated on the same instrument for the second time, which resulted lower than the first repeat result and matched the initial result. The second repeat result was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ferritin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00671 |
| MDR Report Key | 6069409 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-01 |
| Date of Report | 2016-11-01 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2016-10-07 |
| Device Manufacturer Date | 2013-05-06 |
| Date Added to Maude | 2016-11-01 |
| 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, 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 | JMG |
| Date Received | 2016-11-01 |
| 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 |
| Brand Name | ADVIA CENTAUR XP |
| Generic Name | IMMUNOASSAY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-11-01 |
| Model Number | ADVIA CENTAUR XP |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-01 |