MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-04 for RAPIDPOINT 500 10697306 manufactured by Siemens Healthcare Diagnostics.
[44899097]
Siemens is in process of evaluating the event. The root cause for the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[44899098]
Customer reported discordant sodium and potassium results on the instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[48200005]
Siemens investigated the issue. From the data received, it appears that the sodium and potassium sensors were functioning properly. There is no evidence that the sensors were malfunctioning since there was only 1 potassium drift and 3 sodium drifts all of which did not occur on the days of the events. In both incidences on (b)(6), the patient sample had higher recovery for sodium, potassium, and chloride on system (b)(4) than on system (b)(4). Also, glucose and lactate recoveries were lower on system (b)(4) than on system (b)(4). This is consistent with contamination. Most likely, sample on (b)(6) 2016 at 14:03 and sample (b)(6) 2016 at 5:32 on system 31632 were pre-analytical; most likely due to the presence of salt being introduced to the sample from the sample port/luer area ahead of the sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00053 |
| MDR Report Key | 5630036 |
| Date Received | 2016-05-04 |
| Date of Report | 2016-06-17 |
| Date of Event | 2016-04-10 |
| Date Mfgr Received | 2016-05-09 |
| Date Added to Maude | 2016-05-04 |
| 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 |
| 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 | 2016-05-04 |
| 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 | 2016-05-04 |