MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-24 for SIEMENS ADVIA CHEMISTRY 1800 ADVIA 1800 * manufactured by Siemens Healthcare Diagnostics Inc.
[3107781]
Chemistry analyzer had malfunctioning pump which led to erroneously high glucose results being reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2892132 |
| MDR Report Key | 2892132 |
| Date Received | 2012-12-24 |
| Date of Report | 2012-12-24 |
| Date of Event | 2012-11-28 |
| Report Date | 2012-12-24 |
| Date Reported to FDA | 2012-12-24 |
| Date Added to Maude | 2013-01-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIEMENS ADVIA CHEMISTRY 1800 |
| Generic Name | ANALYZER, CHEMISTRY (SEQUENTIAL MULTIPLE, CONTINUOUS FLOW) C |
| Product Code | JJG |
| Date Received | 2012-12-24 |
| Model Number | ADVIA 1800 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| 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 | 2012-12-24 |