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 2017-03-13 for ADVIA 1800 manufactured by Siemens Healthcare Diagnostics Inc..
[69906522]
The customer contacted a siemens customer care center (ccc) specialist. The ccc reviewed the data provided. The customer's quality control (qc) and calibrations were within range at the time of the event. A siemens customer service engineer (cse) was dispatched to the customer's site. The cse adjusted the dilution tray wash unit (dwud) and ran wash2. The cse found the reaction tray wash unit (wud), aspiration probes 2,3 and 4 were clogged. The cse replaced the tubing and cleaned the probes. The cse ran calibration and qc, resulting within range. The cse performed a total service call. The cause of the discordant, falsely elevated carbon dioxide results 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
[69906523]
Discordant, falsely elevated carbon dioxide results were obtained on a patient sample on an advia 1800 instrument. The initial results were not reported out to the physician(s). The customer repeated the same sample (diluted) on the same advia 1800 instrument, resulting elevated. The customer repeated the same sample on an alternate instrument, resulting lower. The customer repeated the same sample on a second alternate instrument, resulting lower. It is unknown if the repeat results were reported out to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated carbon dioxide results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00191 |
| MDR Report Key | 6401501 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-13 |
| Date of Report | 2017-03-13 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-02-13 |
| Date Added to Maude | 2017-03-13 |
| 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 | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | JEOL LTD |
| Manufacturer Street | REGISTRATION #: 3003637681 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 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | CHS |
| Date Received | 2017-03-13 |
| 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 | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-03-13 |
| 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 | 2017-03-13 |