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 2017-01-13 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[64898129]
The customer contacted the siemens customer care center (ccc). The customer stated that quality control (qc) recovery for ferritin was in range in the first attempt, however when qc was repeated , it recovered low out of range. The customer recalibrated ferritin assay and reran qc, which were within range. A siemens customer service engineer (cse) was dispatched to the customer site. The cse performed a complete troubleshooting and discovered that there was bleach contamination in the lines. The cse replaced the bleach valves v66 & v67. The cse then performed daily cleaning and tested for residual bleach. There was no residual bleach. The customer performed qc, which were within range. The cse concluded that the leaking bleach valves were the cause of the contamination. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[64898130]
Discordant, falsely depressed ferritin results were obtained on multiple patient samples on an advia centaur xp instrument. The discordant results were reported to the physician(s). The customer discovered discordant results on (b)(6) samples after repeating samples on the same instrument and additional discordant results on 16 samples which were repeated on an alternate advia centaur instrument, all resulting higher. The corrected results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ferritin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00050 |
| MDR Report Key | 6250879 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-13 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-12-20 |
| Date Mfgr Received | 2016-12-21 |
| Device Manufacturer Date | 2006-04-17 |
| Date Added to Maude | 2017-01-13 |
| 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 AVE |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2017-01-13 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-01-13 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-01-13 |