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 2017-08-11 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[83313172]
The customer contacted the siemens customer care center (ccc) to report the discordant carbon dioxide concentrated (co2_c) results. The quality controls (qc) was in range. A siemens customer service engineer (cse) was dispatched to the customer site. The cse checked the instrument and found that the vacuum was low. The cse replaced diaphragm in pump and ran stylette through reaction tray wash unit (wud) nozzles. The cse revisit the customer site two times. The cse cleaned wud nozzles and rebuilt vacuum pump due to low vacuum. The cse ran quality control (qc) and co2_c patient results, which were in range. The cse cleaned saline and water bottle. The cse found the saline filter dirty and decontaminated the system. The cse replaced reagent dispensing pump 1 (rp1) seals. The cause of the discordant co2_c results is unknown. The instrument is performing according to the specifications. No further evaluation of this device is required. Mdr 2432235-2017-00478 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[83313173]
Discordant, falsely high carbon dioxide concentrated (co2_c) results were obtained on two patient samples on an advia 1800 instrument. The discordant results were not reported to the physician(s). The same samples were repeated on the same instrument, and recovered lower. The repeat results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely high (co2_c) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00477 |
| MDR Report Key | 6789674 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-11 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-07-20 |
| Date Added to Maude | 2017-08-11 |
| 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 | 2017-08-11 |
| 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 | 2017-08-11 |
| 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 | 2017-08-11 |