MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-16 for RAPIDPOINT 500 BLOOD GAS ANALYZER 10697306 manufactured by Siemens Healthcare Diagnostics.
[108902215]
The customer stated that repeat testing was performed to confirm correct results which met the clinical picture and a corrected report was issued. The customer stated that they performed lamp, wavelength and full calibrations. Three levels of qc were run and all were in the expected ranges. The data files have been requested for investigation. The cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[108902216]
The customer reported discrepant total hemoglobin results when tested on the rp 500 and a non-siemens lab analyzer. There was no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2018-00058 |
| MDR Report Key | 7519025 |
| Date Received | 2018-05-16 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-05-02 |
| Date Mfgr Received | 2018-07-10 |
| Date Added to Maude | 2018-05-16 |
| 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 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 | 2018-05-16 |
| Catalog Number | 10697306 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-05-16 |
| Catalog Number | 10697306 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-16 |