MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-15 for ADVIA 1800 073-A021 manufactured by Siemens Healthcare Diagnostics, Inc..
[20416549]
A discordant, falsely high gentamicin result was obtained on the advia 1800 instrument. The laboratory repeated the testing on the same patient sample and obtained a lower gentamicin result. The initial result was not reported to the physician. There are no known reports of adverse health consequences or patient intervention due to the discordant, falsely high gentamicin result.
Patient Sequence No: 1, Text Type: D, B5
[20537384]
A siemens field service engineer (fse) was dispatched to the customer site. After analysis of the instrument, the fse found no instrument issues. The fse did find a clot in the sample and performed a precision on gentamicin, verified alignments and performed a total service call. The cause of the discordant gentamicin result was determined to be caused by the sample clot. The instrument is performing within specification. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00245 |
| MDR Report Key | 2699355 |
| Report Source | 05,06 |
| Date Received | 2012-08-15 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-07-17 |
| Date Mfgr Received | 2012-07-17 |
| Date Added to Maude | 2012-12-04 |
| 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 | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | LCD |
| Date Received | 2012-08-15 |
| Model Number | ADVIA 1800 |
| Catalog Number | 073-A021 |
| Lot Number | N/A |
| ID Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Address | TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-15 |