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 2017-08-22 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[83313230]
The customer contacted the siemens customer care center (ccc) to report two discordant carbon dioxide concentrated (co2_c) results. Quality controls (qc) were in range at the time the event occurred. A siemens customer service engineer (cse) was dispatched to the customer site. While analyzing the instrument, the cse cleaned the reaction tray and dilution tray wash units (wud and dwud) and adjusted the probe alignment. The cse ran precision test, resulting within specification. A siemens headquarters support center (hsc) specialist reviewed the information provided and concluded there is no reagent or method issue associated with this event. The cause of the discordant co2_c result is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[83313231]
Discordant, falsely elevated carbon dioxide concentrated (co2_c) results were obtained on patient samples on an advia chemistry xpt instrument. The discordant results were not reported to the physician(s). The samples were auto-repeated, resulting lower. The repeated results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated co2_c results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00484 |
| MDR Report Key | 6811364 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2017-08-02 |
| Device Manufacturer Date | 2015-09-11 |
| Date Added to Maude | 2017-08-22 |
| 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 | MS. CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION NUMBER: 300363768 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 | CHS |
| Date Received | 2017-08-22 |
| Model Number | ADVIA CHEMISTRY XPT |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | CLINICAL CHEMISTRY ANALYZER, |
| Product Code | JJE |
| Date Received | 2017-08-22 |
| Model Number | ADVIA CHEMISTRY XPT |
| 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 AVENUE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-22 |