MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-08-26 for ADVIA 120 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[19650588]
The instrument data was analyzed by siemens support personnel. After analyzing the instrument data, it was determined that the cause of the discordant result was that the sample was from a patient diagnosed with chronic lymphocytic leukaemia and the sample needed to be run in the 'cbc/differential' mode. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[19846744]
Discordant results for white blood cell count (wbc) were obtained on an advia 120 instrument. The samples were re-tested and the corrected results were reported. There were no reports of adverse health consequences or known patient intervention due to the discordant white blood cell count (wbc) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2011-00121 |
| MDR Report Key | 2224398 |
| Report Source | 05,06 |
| Date Received | 2011-08-26 |
| Date of Report | 2011-08-04 |
| Date of Event | 2011-08-04 |
| Date Mfgr Received | 2011-08-04 |
| Device Manufacturer Date | 2008-09-15 |
| Date Added to Maude | 2012-02-01 |
| 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 | MS. LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD. |
| Manufacturer Street | CHAPEL LANE |
| Manufacturer City | SWORDS, DUBLIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA 120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2011-08-26 |
| Model Number | ADVIA 120 |
| Catalog Number | 067-A004 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 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 | 2011-08-26 |