MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-01-09 for ADVIA 1800 073-A021-01 manufactured by Siemens Healthcare Diagnostics Inc..
[5127979]
A discordant, falsely elevated chloride result was obtained on one patient sample on an advia 1800 instrument. It is unknown if the discordant result was reported to the physician(s). The sample was repeated on the same instrument after recalibration and resulted lower. It is unknown if the corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant chloride result.
Patient Sequence No: 1, Text Type: D, B5
[12644023]
The customer contacted the siemens ccc. The customer stated that they had observed increased chloride values for patient samples. The customer ran quality controls (qc), which were within range but higher than the means. The customer recalibrated and repeated qc, which was then on the mean. Patient samples were repeated and the discordant result was discovered. The cause of the discordant chloride result is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2015-00017 |
| MDR Report Key | 4402400 |
| Report Source | 01,05,06 |
| Date Received | 2015-01-09 |
| Date of Report | 2014-12-17 |
| Date of Event | 2014-12-17 |
| Date Mfgr Received | 2014-12-17 |
| Date Added to Maude | 2015-01-29 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | JEOL LTD. (REGISTRATION # 3003637681) |
| Manufacturer Street | 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 | CGZ |
| Date Received | 2015-01-09 |
| Model Number | ADVIA 1800 |
| Catalog Number | 073-A021-01 |
| 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 | 2015-01-09 |