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 2017-06-23 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[78282165]
The customer contacted the siemens customer care center (ccc) to report the discordant carbon dioxide concentrated (co2_c) result. Quality controls (qc) was in range on the day of event. A siemens customer service engineer (cse) was dispatched to the customer site. The cse discovered the water pressure was too high and the reaction tray wash unit drain valve 1 (cdev1) was not properly working. The cse replaced the valve. The cse ran a precision study, and all was within specifications. Headquarters support center (hsc) has reviewed the information provided and concludes the data is consistent with instrument related issues with the probable cause related to an inoperable cdev1 valve. Qc was repeated and recovery was within expected ranges. 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
[78282166]
A discordant, falsely high carbon dioxide concentrated (co2_c) result was obtained on a patient sample on an advia 1800 instrument. The sample was flagged for hemolysis. The discordant result was not reported to the physician(s). The same sample was repeated on the same advia instruments, and recovered 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 high co2_c result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00376 |
| MDR Report Key | 6663138 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-23 |
| Date of Report | 2017-06-23 |
| Date of Event | 2017-05-30 |
| Date Mfgr Received | 2017-05-30 |
| Date Added to Maude | 2017-06-23 |
| 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 | 3-1-2 MUSASHINO AKISHIMA REGISTRATION#: 3003637681 |
| 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 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | CHS |
| Date Received | 2017-06-23 |
| Model Number | ADVIA 1800 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Brand Name | ADVIA 1800 |
| Generic Name | ADVIA 1800 |
| Product Code | JJE |
| Date Received | 2017-06-23 |
| Model Number | ADVIA 1800 |
| 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 AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-23 |