MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-05 for ADVIA 1800 073-A021-01 manufactured by Siemens Healthcare Diagnostics Inc..
[17837729]
Three patient samples resulted falsely low and one patient sample resulted with slash-marks (/////) for digoxin on an advia 1800 instrument. The results were reported to the physician(s). When the operator reran quality controls (qc) for digoxin as scheduled, the qc was out of range. The operator recalibrated the instrument and reran qc, which was within range. Patient samples tested prior to the recalibration were then run, and the four samples were discordant. The corrected results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant digoxin results.
Patient Sequence No: 1, Text Type: D, B5
[18072232]
A siemens field service engineer was dispatched to the customer site. After evaluation of the instrument and instrument data, the fse discovered a leak in reagent probe 2 and the dip pump. The fse replaced the 5 mm seal and the 1 mm seal to address the leaks. The system was recalibrated and qc was run, all of which were within range. Patient samples were run and resulted as expected. The cause of the discordant digoxin results was due to the out-of-range qc. The cause of the qc being out-of-range is unknown, as qc came into range and patient samples resulted as expected on the same instrument prior to the service visit. This instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00428 |
| MDR Report Key | 3328001 |
| Report Source | 05,06 |
| Date Received | 2013-09-05 |
| Date of Report | 2013-08-12 |
| Date of Event | 2013-08-12 |
| Date Mfgr Received | 2013-08-12 |
| Date Added to Maude | 2013-12-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 | KXT |
| Date Received | 2013-09-05 |
| Model Number | ADVIA 1800 |
| Catalog Number | 073-A021-01 |
| 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 | 2013-09-05 |