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.
[48001865]
Siemens is in process of evaluating the event. Customer has been requested to provide additional files to investigate the event. The root cause for the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[48001866]
Customer stated that instrument reported 3 falsely elevated sodium results compared to alternate instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[48647562]
There is evidence of benzalkonium interference routinely throughout the use life of the cartridge installed on sn (b)(4). Benzalkonium is a known interfering substance as listed in the rp500 operator's manual. The sensor had been exposed numerous times throughout the use of this cartridge causing intermittent na calibration errors. The source of the contamination should be investigated and eliminated. There were no system or sample errors occurring on instrument (b)(4) on (b)(6) when the suspect samples were run. There were differences in recovery on na, k, cl, thb and lactate suggesting pre-analytical factors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00063 |
| MDR Report Key | 5703634 |
| Date Received | 2016-06-07 |
| Date of Report | 2016-07-01 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2016-06-20 |
| 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 |