MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-08-26 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..
[53295004]
The customer contacted siemens customer care center (ccc). The precision check data provided from ten samples, shows the coefficient of variation is out of range. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[53295005]
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). The same sample was tested on the same advia centaur xp instrument in duplicate, resulting higher. The customer then ran the same sample in triplicate on an alternate advia centaur instrument, resulting higher than the original result. The customer released the first repeat on the original instrument 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
[57602240]
The initial mdr 2432235-2016-00525 was filed on august 26, 2016. Additional information (08/05/2016): a siemens customer service engineer (cse) was dispatched to the customer's site. The cse replaced the ancillary probe. The cse then ran quality control (qc), which resulted in range. 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
| Report Number | 2432235-2016-00525 |
| MDR Report Key | 5909278 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-26 |
| Date of Report | 2016-09-23 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-08-05 |
| Device Manufacturer Date | 2007-08-13 |
| Date Added to Maude | 2016-08-26 |
| 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 | 9145252406 |
| 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 | 2016-08-26 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-08-26 |
| Model Number | ADVIA CENTAUR XP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-08-26 |