MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-02-07 for ADVIA 120 067-A004 manufactured by Siemens Healthcare Diagnostics Inc..
[2535078]
Advia 2120 software version 5. 8 was installed on an advia 120 hematology analyzer. The customer noted that the advia 120 analyzer was used to generate reti (reticulocyte) parameters only, which were reported out for approximately forty (40) patients over a period of four (4) months. There were no known reports of discordant patient values or adverse health consequences due to the installation of the advia 2120 software on the advia 120 analyzer. There were no known reports of patient treatment being delayed, altered, or prescribed due to the installation of the advia 2120 software on the advia 120 analyzer.
Patient Sequence No: 1, Text Type: D, B5
[9622331]
The advia 2120 software version 5. 8 had been installed in the customer's advia 120 analyzer by a siemens field service engineer (fse). Siemens became aware of the installation of the advia 2120 software in the advia 120 analyzer when a siemens fse was dispatched to install a second advia 120 analyzer at the customer's facility. The customer stopped using the advia 120 analyzer with incorrect software as of (b)(6) 2012. A siemens healthcare diagnostics field service engineer (fse) was dispatched to the customer site for instrument evaluation. After evaluating the instrument, the fse removed the advia 2120 version 5. 8 software and installed the correct advia 120 software version 3. 2. 3. The customer then resumed using the advia 120. The analyzer is operating according to specifications. No further evaluation of the analyzer is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00024 |
| MDR Report Key | 2441554 |
| Report Source | 07 |
| Date Received | 2012-02-07 |
| Date of Report | 2012-01-17 |
| Date of Event | 2012-01-17 |
| Date Mfgr Received | 2012-01-17 |
| Device Manufacturer Date | 2003-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 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 120 |
| Generic Name | HEMATOLOGY ANALYZER |
| Product Code | GKL |
| Date Received | 2012-02-07 |
| Model Number | ADVIA 120 |
| Catalog Number | 067-A004 |
| 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 | 2012-02-07 |