MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-12-02 for SYNGO LAB DATA MANAGER APPLICATION SOFTWARE manufactured by Siemens Healthcare Diagnostics Inc..
[61400814]
The customer contacted the siemens customer care center (ccc). Ccc connected remotely and checked a patient sample. Ccc discovered that data was not purged after 30 days as configured. A siemens headquarter support center (hsc) specialist connected remotely and performed a data base clean up, purge and defragmentation. Hsc checked the database, and no issues were noted. The cause of the database not purging as configured is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[61400815]
The (b)(4) lab data manager was not purging data as configured, causing results to stay in the system past the time period configured. The customer reuses barcodes every 90 days, and discovered that old results were being confused with new orders and the same barcodes were associated with different patients. There were no incorrect results or data reported out by the customer. There are no known reports of patient intervention or adverse health consequences due to the (b)(4) not purging data as configured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2016-00484 |
| MDR Report Key | 6142011 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-12-02 |
| Date of Report | 2016-12-02 |
| Date of Event | 2016-11-03 |
| Date Mfgr Received | 2016-11-03 |
| Date Added to Maude | 2016-12-02 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGARITA KARAN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243105 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNGO LAB DATA MANAGER APPLICATION SOFTWARE |
| Generic Name | SYNGO LAB DATA MANAGER APPLICATION SOFTWARE |
| Product Code | NSX |
| Date Received | 2016-12-02 |
| Model Number | SYNGO LAB DATA MANAGER APPLICATION SOFTWARE |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE NEWARK DE 19702 US 19702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-02 |