MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-11 for ADVIA 1800 073-A021-01 manufactured by Siemens Healthcare Diagnostics Inc..
[4583625]
Discordant, falsely low chloride results were obtained on multiple patient samples on an advia 1800 instrument. The discordant chloride results were reported to the physician(s). The samples were repeated on an alternate system and reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant chloride results.
Patient Sequence No: 1, Text Type: D, B5
[12075130]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse evaluated the instrument and instrument data. After instrument evaluation, the cse determined that the equilibration chamber motor was not operational. The cse replaced the equilibration chamber, buffer pump seals and ion selective electrode tubing. The cse calibrated the ion selective electrodes and determined that the customer previously replaced the chloride electrode. The cause of the discordant chloride results was due to a equilibration chamber malfunction. The cse successfully ran quality controls. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00416 |
| MDR Report Key | 3930458 |
| Report Source | 05,06 |
| Date Received | 2014-07-11 |
| Date of Report | 2014-06-18 |
| Date of Event | 2014-06-18 |
| Date Mfgr Received | 2014-06-18 |
| Date Added to Maude | 2014-07-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | JEOL LTD, 3-1-2 MUSASHINO AKISHIMA |
| Manufacturer Street | REGISTRATION NUMBER:3003637681 |
| Manufacturer City | TOKYO, 196-8558 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 196-8558 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | CGZ |
| Date Received | 2014-07-11 |
| 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 | 2014-07-11 |