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 2017-09-21 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[88070838]
The customer contacted the siemens customer care center (ccc). The customer ran quality controls, resulting with error flags. A siemens customer service engineer (cse) was at the customer site. After inspecting the instrument, the cse replaced the reagent probe 2 mix paddle, solenoid reagent probe valve 2, and lamp. The cse checked all valves. The customer ran quality control (qc), resulting acceptable. The cause of the discordant, falsely elevated po4 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
[88070839]
A discordant, falsely elevated inorganic phosphorus (po4) result was obtained on a patient sample on an advia chemistry xpt instrument. The discordant result was not reported to the physician(s). The sample was repeated on an alternate instrument, resulting lower. The repeated result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant falsely elevated po4 result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00519 |
| MDR Report Key | 6884309 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-08-27 |
| Date Mfgr Received | 2017-08-29 |
| Device Manufacturer Date | 2015-06-10 |
| Date Added to Maude | 2017-09-21 |
| 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. MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION NUMBER: 300363768 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer City | TOKYO 196-8558, |
| Manufacturer Country | JA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY XPT |
| Generic Name | ADVIA CHEMISTRY XPT |
| Product Code | CEO |
| Date Received | 2017-09-21 |
| 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 | ADVIA CHEMISTRY XPT |
| Product Code | JJE |
| Date Received | 2017-09-21 |
| 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 | 2017-09-21 |