MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-09-05 for ADVIA 1800 073-A021-01 manufactured by Siemens Healthcare Diagnostics Inc..
[4857037]
Discordant chloride results were obtained on two patient samples on an advia 1800 instrument. The discordant results were not reported to the physician(s). The samples were repeated on an alternate instrument, one of which was higher and one of which was lower than their initial results. It is unknown if the results from the alternate instrument(s) were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant chloride results.
Patient Sequence No: 1, Text Type: D, B5
[12327551]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument, the cse discovered that the ion selective electrode (ise) module was dirty. The cse cleaned the ise module and recalibrated the instrument. Quality controls were run and resulted within range and patient samples were repeated with acceptable results. The cause of the discordant chloride results 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 | 2432235-2014-00534 |
| MDR Report Key | 4065516 |
| Report Source | 05,06 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-08-12 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-08-12 |
| Date Added to Maude | 2014-09-19 |
| 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 | 2014-09-05 |
| 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 | 2014-09-05 |