MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-03-15 for RAPIDPOINT 500 10492730 manufactured by Siemens Healthcare Diagnostics.
[40390941]
Siemens customer product support investigated the event and concluded following: the customer was unable to provide sample times or id's but stated they were run sometime on the (b)(6), before 14:51 when the complaint was received by siemens. From the provided files, the attempt to match the provided information was made. Data is inconclusive from the data provided as to which samples were truly suspect. Moreover, instrument (b)(4) experienced numerous occurrences of benzalkonium exposure during use life. This is a known interfering substance for the sodium sensor as listed in the rp500 operators manual.
Patient Sequence No: 1, Text Type: N, H10
[40390942]
Customer reported that pco2 result did not correlate with their other rp500. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217157-2016-00029 |
| MDR Report Key | 5501570 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-03-15 |
| Date of Report | 2016-03-15 |
| Date of Event | 2016-02-16 |
| Date Mfgr Received | 2016-02-16 |
| Date Added to Maude | 2016-03-15 |
| 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 |
| 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 | 2016-03-15 |
| Catalog Number | 10492730 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2016-03-15 |