MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-24 for RAPIDPOINT 500 10697306 manufactured by Siemens Healthcare Diagnostics.
[46217464]
Siemens is in process of evaluating the event. The root cause for the event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[46217465]
Customer reported falsely low potassium result on the rp 500 when compared to alternate instrument. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
[50137835]
Customer provided incomplete information. A review of the available data could not determine any rationale for the decreased k+ value on the specified specimen. From the information provided, there is no evidence that the potassium sensor on this system at the time of testing was not performing as intended. The aqc results easily passed expectations (calculated mean matched target mean and standard deviation was low for all three aqc levels tested) and the millivolt response curves for the k+ sensor during the time period looked typical.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217157-2016-00062 |
| MDR Report Key | 5675987 |
| Date Received | 2016-05-24 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2016-06-27 |
| Date Added to Maude | 2016-05-24 |
| 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 | 2016-05-24 |
| 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 | 2016-05-24 |