MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-04 for RAPIDPOINT 405 10322347 manufactured by Siemens Healthcare Diagnostics.
[42521238]
Siemens global product support received the trace log and sensor data from customer. After review of data the instrument was proved not at fault. The issue is determined to be completely an operator error. Review showed that the customer was using the last patient option is enabled. (this is turned on by selecting save demographics on the analysis options screen in setup under secured options). This is an incorrect use of this feature which is only meant for repeated samples from the same patient in an or type environment. Unless this instrument is in an operating room or otherwise dedicated to running multiple samples for the same patient back-to-back-to-back the option in setup -> secured options -> analysis options for "save demographics" (which adds the "last patient" button to the patient data entry screen) should be de-selected. The "last patient" button was intended to support a very specific niche need (operating rooms where the operator will need to run many samples for the same patient over and over and wanted a way to quickly populate patient demographics with a single button click so that they could get back to tending to their patient). All other situations should have this option turned off. Customer was explained that save demographics should be deselected (turned off with no checkmark so the same patient information will not stay in analyzer for the next sample). Only in departments where the operator needs to run many samples on the same patient over and over again (e. G. Operating room) would it be selected. Customer understood given explanation and does not need any further assistance from siemens. System is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[42521239]
Customer reported that they scanned a patient result and the result was reported out under the incorrect patient. Customer indicated that she verified paper printout label with the rp 405 display. Customer also indicated that results were reported to the physician but physician was notified that results were incorrect. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2016-00039 |
| MDR Report Key | 5544760 |
| Date Received | 2016-04-04 |
| Date of Report | 2016-04-04 |
| Date of Event | 2016-03-09 |
| Date Mfgr Received | 2016-03-10 |
| Date Added to Maude | 2016-04-04 |
| 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 | 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 | 0 |
| Brand Name | RAPIDPOINT 405 |
| Generic Name | RP 405 |
| Product Code | GKR |
| Date Received | 2016-04-04 |
| Catalog Number | 10322347 |
| Device Availability | Y |
| 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 | 2016-04-04 |