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 2017-10-12 for SYNGO LAB DATA MANAGER APPLICATION SOFTWARE manufactured by Siemens Healthcare Diagnostics Inc..
[90295503]
The customer contacted the siemens customer care center (ccc). Ccc connected remotely and reviewed the data logs. The patient sample was placed on the track at 10:30 and the results were in syngo by 10:46 for all tests. The customer has the magnesium set up to hold for magnesium therapeutic which means the technician has to release this test. Review of the audit trail indicated that the magnesium was in held status and was not released until 11:46 by the technician. Syngo performed as intended. Ccc discussed the user error with the laboratory supervisor. The cause of the delay was due to a user error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[90295504]
The customer reported that a magnesium therapeutic patient result took over an hour to be reported from the syngo lab data manager to the laboratory information system. The customer received a complaint from the physician regarding the delay. There are no known reports of patient intervention or adverse health consequences due to the delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00773 |
| MDR Report Key | 6946370 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-09-15 |
| Date Added to Maude | 2017-10-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 2017-10-12 |
| 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 | 2017-10-12 |