MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-20 for ADVIA 2120I WITH AUTOSAMPLER 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[18306600]
A discordant low hemoglobin (hgb) result was obtained with one (1) patient sample on an advia 2120i analyzer. The discordant low hgb result was reported to the physician. The patient was admitted and further testing was performed on another sample. The patient was not transfused. There are no known reports of adverse health consequences due to the discordant hgb result.
Patient Sequence No: 1, Text Type: D, B5
[18323019]
A siemens fse (field service engineer) was dispatched to the customer site. The fse analyzed the advia 2120i instrument data and performed an instrument check. Analysis of the instrument data indicates that the cause for the discordant hcg result is unknown. The fse re-aligned the shear valve dispense position, checked the system vacuum and pressure, replaced the rbc sample syringe pump and syringe and replaced pilot valves. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00452 |
| MDR Report Key | 2882863 |
| Report Source | 05,06 |
| Date Received | 2012-12-20 |
| Date of Report | 2012-12-04 |
| Date of Event | 2012-12-03 |
| Date Mfgr Received | 2012-12-04 |
| Device Manufacturer Date | 2011-06-04 |
| Date Added to Maude | 2013-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | CHAPEL LANE SWORDS |
| Manufacturer City | DUBLIN, |
| Manufacturer Country | EI |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 2120I WITH AUTOSAMPLER |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-12-20 |
| Model Number | ADVIA 2120I |
| Catalog Number | 067-A004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| 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 | 2012-12-20 |