MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for RAPIDPOINT 500 BLOOD GAS ANALYZER 10697306 manufactured by Siemens Healthcare Diagnostics.
[97873577]
The customer reported that repeat testing was performed to confirm correct results. The customer was asked to provide the measurement cartridge but it is no longer available. The printout for the initial result shows a question mark after the value (7. 1? ). That symbol is for a questionable result as referred to in the operator's manual. There will be an investigation on the uploaded data files. The customer reported they are operational.
Patient Sequence No: 1, Text Type: N, H10
[97873578]
The customer reported discrepant total hemoglobin (thb) results with two different blood samples on two rp 500 systems. In addition, a sample was run on a non-siemens chemistry analyzer for comparative analysis. There is no report of injury due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002637618-2018-00004 |
| MDR Report Key | 7198856 |
| Date Received | 2018-01-17 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-03-28 |
| Date Added to Maude | 2018-01-17 |
| 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 | 2018-01-17 |
| 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 | 2018-01-17 |
| 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 | 2018-01-17 |