MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for RAPIDPOINT 500 BLOOD GAS ANALYZER 10697306 manufactured by Siemens Healthcare Diagnostics.
[79759361]
Siemens reviewed the data files. The thb results of the two patients' specimens in question appear to be valid. Co-ox diagnostic information indicates that the co-ox slide cell was stable and consistent during this testing period, showed no chronic co-ox related issues across the life of the mcart and thb recovery for the aqc samples were in range. The root-cause for the dissimilar thb results could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[79759362]
The customer reported discrepant elevated total hemoglobin results for two patients when run on the rp 500. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2017-00111 |
| MDR Report Key | 6699144 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 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 | 0 |
| Brand Name | RAPIDPOINT 500 BLOOD GAS ANALYZER |
| Generic Name | RP 500 |
| Product Code | GKR |
| Date Received | 2017-07-10 |
| Catalog Number | 10697306 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | 511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591 |
| Brand Name | RAPIDPOINT 500 BLOOD GAS ANALYZER |
| Generic Name | RP 500 |
| Product Code | CHL |
| Date Received | 2017-07-10 |
| Catalog Number | 10697306 |
| 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 | 2017-07-10 |