MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-15 for RAPIDPOINT 405 10320055 manufactured by Siemens Healthcare Diagnostics.
[55219572]
Based on the data, the na+ and cl- both experienced a calibration drift after this sample was run on the rp405 instrument. The customer was asked if lithium heparin blood collection device was used to collect the specimen. They confirmed that in fact na heparin was used which would increase the sodium concentration of the specimen. Note there are periods during use life where there is evidence of benzalkonium in use. Benzalkonium is a known interferent on the rapidpoint 400/405/500 na+ sensor. The source of this substance should be located and removed to avoid this contamination. The instrument is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[55219573]
The customer suspected a discordant sodium (na+) result on one patient sample on rp405 sn (b)(4) vs. The main laboratory result run on a gem4000. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2016-00105 |
| MDR Report Key | 5953382 |
| Date Received | 2016-09-15 |
| Date of Report | 2016-09-15 |
| Date of Event | 2016-08-25 |
| Date Mfgr Received | 2016-08-30 |
| Date Added to Maude | 2016-09-15 |
| 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 INDUSTRY |
| 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 | 2016-09-15 |
| Catalog Number | 10320055 |
| Operator | NURSE |
| 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 NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-15 |