MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-04-19 for ADVIA 120 067-A004-13 manufactured by Siemens Healthcare Diagnostics.
[16434242]
A discordant advia 120 hemaglobin ( hgb) result was obtained on a patient sample. The result was reported to the physician. The laboratory repeated the sample and a new sample was redrawn and tested. The corrected result was reported to the physician. The nursing home patient was sent to the hospital. There are no known reports of adverse health consequences due to the discordant hgb result.
Patient Sequence No: 1, Text Type: D, B5
[16627218]
A siemens field service engineer ( fse) evaluated the advia 120 instrument and instrument data. The fse flushed all the pathways. Replaced the rbc sample syringe and the flowcell tubing, refocused the laser with optipoint and adjusted the gains accordingly, ran qc. The system is operational. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00127 |
| MDR Report Key | 2540335 |
| Report Source | 05,06 |
| Date Received | 2012-04-19 |
| Date of Report | 2012-04-09 |
| Date of Event | 2012-04-04 |
| Date Mfgr Received | 2012-04-09 |
| Device Manufacturer Date | 2004-01-06 |
| Date Added to Maude | 2012-09-12 |
| 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 | ELIZABETH BEATO |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243074 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | MANUFACTURING LIMITED CHAPEL LANE |
| Manufacturer City | SWORD, CO 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 | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-04-19 |
| Model Number | ADVIA 120 |
| Catalog Number | 067-A004-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-19 |