MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-27 for RAPIDPOINT 405 10322347 manufactured by Siemens Healthcare Diagnostics.
[18636208]
Customer stated that erroneous patient demographics were reported on (b)(6) patient ids. Customer indicated that they did not know whether instrument or rapidcomm (data management) was affected. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[19135378]
Siemens field service engineer (fse) turned off rapid sample identification and rebooted analyzer. Review of the trace logs showed patient b was edited at the analyzer, other samples were not. Customer confirmed that there was no delay in patient treatment or interventions due to this event. Customer indicated that after rebooting the analyzer no further issues have been reported with incorrect demographics. System is operational. The cause for the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[31928492]
The cause for the issue is due to save demographics setting being turned 'on' on the instrument. Siemens technical operation team assisted customer to turn off save demographics. Customer indicated that they have been unable to reproduce the issue after implementing the changes suggested by siemens tech ops.
Patient Sequence No: 1, Text Type: N, H10
[32674244]
Customer verbally reported to siemens representative that same incident of incorrect demographics had occurred again on (b)(6) 2015. Siemens customer care center requested customer to provide additional information for further investigation. Customer indicated that they could not and would not give any specifics.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2015-00051 |
| MDR Report Key | 4730338 |
| Report Source | 06,07 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-03-30 |
| Date of Event | 2015-03-30 |
| Date Mfgr Received | 2015-05-11 |
| Date Added to Maude | 2015-05-28 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVEN ANDBERG |
| Manufacturer Street | 2 EDGEWATER DRIVE |
| Manufacturer City | NORWOOD MA 02062 |
| Manufacturer Country | US |
| Manufacturer Postal | 02062 |
| Manufacturer Phone | 7812693655 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD. |
| Manufacturer Street | NORTHERN ROAD CHILTON INDUSTRIAL ESTATE |
| Manufacturer City | SUDBURY CO102XQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CO10 2XQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPIDPOINT 405 |
| Generic Name | RP 405 |
| Product Code | GKR |
| Date Received | 2015-04-27 |
| Catalog Number | 10322347 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-27 |