MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-07 for RAPIDPOINT 500 10697306 manufactured by Siemens Healthcare Diagnostics.
[48005963]
Siemens representative was onsite and ran two patient comparisons between the lab rp405 and the ed rp500 and results were similar from both the devices: (b)(6). Siemens is in process of evaluating the event. Customer has been requested to return measurement cartridge to investigate the event. The root cause for the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[48005964]
Customer reported discordant sodium, potassium and chloride results on the instrument when compared to alternate instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[49056946]
Instrument files from rp500 sn (b)(4) were analyzed. Information from the rp405 was not available for analysis. Measurement cartridge (b)(4 )was installed on may 9, 2016. The discordant results occurred on (b)(6). The measurement cartridge was not available for return. From the instrument files, na was performing typically and aqc samples, including on the day of the discordant results was within published ranges. There were no system errors or calibration errors occurring on that day. The customer reportedly changed the measurement cartridge and performed additional side by side comparisons. This data was not supplied. Field service was dispatched to verify proper valve alignment on june 29, 2016. The instrument was found to be out of alignment and was re-aligned at the visit. The cause of the discordant results cannot be ascertained. Field service found the instrument to be out of alignment and realigned the valve.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00064 |
| MDR Report Key | 5704010 |
| Date Received | 2016-06-07 |
| Date of Report | 2016-07-08 |
| Date of Event | 2016-05-17 |
| Date Mfgr Received | 2016-07-07 |
| Date Added to Maude | 2016-06-07 |
| 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 | 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 | 3 |
| Brand Name | RAPIDPOINT 500 |
| Generic Name | RP 500 |
| Product Code | GKR |
| Date Received | 2016-06-07 |
| Catalog Number | 10697306 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-06-07 |