MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-01 for ADVIA 1800 073-A020 manufactured by Siemens Healthcare Diagnostics Inc..
[15024631]
A discordant high result for gentamicin was obtained on an advia 1800 instrument. The result was reported out and the physicians questioned it. The same sample was rerun five times on the same instrument and the results were lower and with good reproducibility. There are no known reports of patient intervention or adverse health consequences due to the low gentamicin result.
Patient Sequence No: 1, Text Type: D, B5
[15293640]
The cause of a single discordant high gentamicin result is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00288 |
| MDR Report Key | 2723782 |
| Report Source | 05,06 |
| Date Received | 2012-09-01 |
| Date of Report | 2012-07-29 |
| Date of Event | 2012-07-29 |
| Date Mfgr Received | 2012-07-29 |
| Date Added to Maude | 2012-12-18 |
| 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 | MR. JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LCD |
| Date Received | 2012-09-01 |
| Model Number | ADVIA 1800 |
| Catalog Number | 073-A020 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2012-09-01 |