MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-31 for ADVIA 120 067-A004-13 manufactured by Siemens Healthcare Diagnostics, Inc..
[2516323]
Discordant low hemoglobin results were obtained on the advia 120 for two patients. The results were reported to the physician(s) the samples were repeated for confirmation on the same system and corrected reports were sent out. There is no known report of adverse health consequences due to the discordant hemoglobin results.
Patient Sequence No: 1, Text Type: D, B5
[9618201]
The customer contacted the technical service center and was directed to flush the hgb reagent lines, which resolved the issue. In addition, a siemens fse (field service engineer) evaluated the advia 120 instrument and instrument data. Upon evaluating the instrument, the fse adjusted the laser and ran qc. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00021 |
| MDR Report Key | 2433251 |
| Report Source | 05,06 |
| Date Received | 2012-01-31 |
| Date of Report | 2012-01-06 |
| Date of Event | 2012-01-06 |
| Date Mfgr Received | 2012-01-06 |
| Device Manufacturer Date | 2010-12-23 |
| Date Added to Maude | 2012-07-31 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTIC MANUFACTURING LTD |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS, DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-01-31 |
| Model Number | ADVIA 120 |
| Catalog Number | 067-A004-13 |
| Lot Number | N/A |
| ID Number | N/A |
| 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 | 2012-01-31 |