MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-03 for DIMENSION CLINICAL CHEMSITRY SYSTEM RXL MAX W/HM manufactured by Siemens Healthcare Diagnostics Inc.
[3162966]
Discordant sodium (na) results were obtained on a dimension rxl max instrument for multiple patients. The discordant results were reported to the physicians, who questioned the results. The customer repeated the same samples on two other instruments and the corrected results were reported to the physicians. There are no known reports of patient intervention or adverse health consequences due to the discordant na results.
Patient Sequence No: 1, Text Type: D, B5
[10825902]
A siemens field service engineer (fse) was dispatched to the customer site. The fse analyzed the instrument and instrument data and determined the cause of the discordant sodium results was unknown. The fse replaced the mono pump home sensor, ran the diluent check and qc and determined the qc results were within the acceptable ranges. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2013-00199 |
| MDR Report Key | 3093053 |
| Report Source | 05,06 |
| Date Received | 2013-05-03 |
| Date of Report | 2013-04-03 |
| Date of Event | 2013-03-26 |
| Date Mfgr Received | 2013-04-03 |
| Device Manufacturer Date | 2008-12-31 |
| Date Added to Maude | 2013-07-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION CLINICAL CHEMSITRY SYSTEM |
| Generic Name | CLINICAL CHEMSITRY SYSTEM |
| Product Code | NGS |
| Date Received | 2013-05-03 |
| Model Number | RXL MAX W/HM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-03 |