MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-15 for ADVIA 120 10310973 manufactured by Siemens Healthcare Diagnostics Inc..
[21403901]
A siemens field service engineer (fse) was sent to the customer site. After analyzing the instrument and instrument data, the fse determined that the cause of the discordant hemoglobin result was poor aspiration of sample. The discordant result was flagged with a sample/system flag. The operator is required to take further action when flags occur. The fse cleaned the sample pathway and replaced syringes, tubings and filters, which resolved this issue. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[21417597]
A discordant result for hemoglobin (hgb) was obtained on an advia 120 instrument. The initial result was reported to the physician. The sample was re-tested and the corrected result reported. There were no reports of adverse health consequences or known patient intervention due to the discordant hemoglobin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2012-00375 |
| MDR Report Key | 2832931 |
| Report Source | 05,06 |
| Date Received | 2012-11-15 |
| Date of Report | 2012-10-17 |
| Date of Event | 2012-10-17 |
| Date Mfgr Received | 2012-10-17 |
| Device Manufacturer Date | 2004-06-27 |
| Date Added to Maude | 2013-02-22 |
| 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. RANJAN SADARANGANI |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242868 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS 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 | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-11-15 |
| Model Number | ADVIA 120 |
| Catalog Number | 10310973 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | 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 | 2012-11-15 |