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 2017-04-17 for ADVIA CENTAUR XPT manufactured by Siemens Healthcare Diagnostics Inc..
[73074704]
The customer contacted a siemens customer care center (ccc) specialist. The ccc reviewed the data provided. The ccc found the region service center (rsc) replaced valves 66, 67, 77 and 78 previously. Siemens is investigating the event.
Patient Sequence No: 1, Text Type: N, H10
[73074705]
Discordant, falsely depressed c-peptide results were obtained on an advia centaur xpt instrument. The customer stated the first test reported out by the advia centaur xpt instrument is always low. It is unknown if any of the discordant results were reported out to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed c-peptide results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00269 |
| MDR Report Key | 6499101 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-17 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-03-07 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2016-04-25 |
| Date Added to Maude | 2017-04-17 |
| 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 | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO, 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CENTAUR XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JKD |
| Date Received | 2017-04-17 |
| Model Number | ADVIA CENTAUR XPT |
| 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 XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-04-17 |
| Model Number | ADVIA CENTAUR XPT |
| 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 | 2017-04-17 |