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 2017-05-12 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[75101746]
A siemens headquarters support center (hsc) reviewed the event. Hsc reviewed the data and service reports provided. Hsc found this was not a method or reagent lot issue. A siemens customer service engineer (cse) was dispatched to the customer's site and corrected the issue. The cse performed decontamination, replaced the clot sensor, replaced the vacuum valves of the reagent tray wash station (wud) and replaced the j1 manifold. No further issues have been reported related to this event. The cause of the discordant, falsely depressed blood urea nitrogen concentrate results 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
[75101747]
Discordant, falsely depressed blood urea nitrogen concentrate results were obtained on multiple patient samples on an advia chemistry xpt instrument. The initial results were not released to the physician(s). The customer repeated the same sample on an alternate advia chemistry xpt instrument, resulting higher. For sample id: (b)(6), the customer repeated the same sample on the same instrument, resulting higher. The customer reported the alternate instrument results and the repeat result for sample id: (b)(6) to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed blood urea nitrogen concentrate results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00317 |
| MDR Report Key | 6565221 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-12 |
| Date of Report | 2017-07-19 |
| Date of Event | 2017-04-09 |
| Date Mfgr Received | 2017-07-19 |
| Date Added to Maude | 2017-05-12 |
| 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 CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CDQ |
| Date Received | 2017-05-12 |
| Model Number | ADVIA CHEMISTRY 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 CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-12 |
| Model Number | ADVIA CHEMISTRY 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 | 2017-05-12 |