MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-16 for ADVIA 1800 073-A020-XX manufactured by Siemens Healthcare Diagnostics Inc..
[3072622]
A discordant low result for phenytoin (phny_2) was obtained on an advia 1800 instrument. The result was reported to the physicians. The customer received a higher result for free phenytoin. The customer reran the same sample on a different instrument and obtained a higher result. The corrected result was reported to the physicians. The patient was treated with additional dilantin based on the original low result. There are no known reports of adverse health consequences due to the discordant low phny_2 result.
Patient Sequence No: 1, Text Type: D, B5
[10235093]
A siemens field service engineer (fse) was dispatched to the customer site. The fse analyzed the instrument and determined the cause of the discordant phny_2 result was that reagent probe 2 was not seated properly. The fse reseated the probe. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00346 |
| MDR Report Key | 2792407 |
| Report Source | 05,06 |
| Date Received | 2012-10-16 |
| Date of Report | 2012-09-20 |
| Date of Event | 2012-09-19 |
| Date Mfgr Received | 2012-09-20 |
| Date Added to Maude | 2013-01-30 |
| 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. MICHAEL METZ |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Single Use | 0 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 1800 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | DKH |
| Date Received | 2012-10-16 |
| Model Number | ADVIA 1800 |
| Catalog Number | 073-A020-XX |
| 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 | 2012-10-16 |