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 2017-08-31 for ADVIA CHEMISTRY XPT manufactured by Siemens Healthcare Diagnostics Inc..
[84362407]
The customer contacted the siemens customer care center (ccc) and stated that quality control (qc) was within range on the day the event occurred. A siemens customer service engineer (cse) was dispatched to the customer site. After inspecting the instrument, the cse replaced the dilution tray (dtt), reaction tray (rrv) cuvette and lamp. The cse performed cell blank and register lamp. The cse ran a shutdown wash. The cse ran qc, which passed. The cause of the discordant, falsely low lip 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
[84362408]
A discordant, falsely low lipase (lip) 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 the same instrument, resulting higher. 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 low lip result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00491 |
| MDR Report Key | 6835559 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-31 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-01 |
| Date Mfgr Received | 2017-08-01 |
| Date Added to Maude | 2017-08-31 |
| 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 |
| 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 | CHI |
| Date Received | 2017-08-31 |
| 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 | 2017-08-31 |
| 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 | 2017-08-31 |