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 2016-08-18 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[52502979]
A customer called in to a siemens customer care center (ccc) specialist stating they are experiencing failing calibrations due to high coefficient of variation (cv) and intermittent signal errors. A siemens customer service engineer (cse) specialist was dispatched to the customer's site. The cse performed a total service call. The cse found that the acid pump was leaking and replaced the acid pump. The cse found aspirate probe 3 and reagent probe 3 were bent and replaced both probes. The cse found a loose probe 1 wash bowl and tightened it. The cse repaired 2 pinch valves. The cse then recalibrated and ran fresh quality control (qc), which passed. The cause of the discordant, falsely depressed ferritin result 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
[52502980]
A discordant, falsely depressed ferritin (fer) result was obtained on a patient sample on an advia centaur xp instrument. The initial result was not reported out to the physician(s). A second sample was tested on the same advia centaur xp instrument, resulting above the assay range. The customer diluted the sample (1:10) and repeated the test, resulting higher than original sample and matching the patients clinical history. The repeat result was reported out to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed ferritin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00489 |
| MDR Report Key | 5887379 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-18 |
| Date of Report | 2016-08-18 |
| Date of Event | 2016-07-24 |
| Date Mfgr Received | 2016-07-24 |
| Device Manufacturer Date | 2007-09-17 |
| Date Added to Maude | 2016-08-18 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD |
| Manufacturer Street | REGISTRATION NUMBER: 8020888 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JMG |
| Date Received | 2016-08-18 |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2016-08-18 |
| 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 | 2016-08-18 |