MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-06-28 for DIMENSION RXL MAX W/O HM DIMENSION RXL MAX W/ HM manufactured by Siemens Healthcare Diagnostics Inc..
[15205833]
A discordant, falsely elevated gentamicin result was obtained for one patient sample on a dimension rxl max w/o hm instrument. The discordant result was reported to the physician(s), who questioned the result. The sample was then rerun twice on this instrument and each time resulted lower. The rerun results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated gentamicin result.
Patient Sequence No: 1, Text Type: D, B5
[15541293]
The customer contacted the siemens technical solutions center (tsc). After evaluation of the instrument data, the tsc specialist discovered that the r2 probe needed replacement. The customer replaced the r2 probe and the instrument is functioning as expected. The cause of the discordant, falsely elevated gentamicin result is due to a malfunction of the r2 probe. This instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2013-00287 |
| MDR Report Key | 3195725 |
| Report Source | 05,06 |
| Date Received | 2013-06-28 |
| Date of Report | 2013-06-03 |
| Date of Event | 2013-06-03 |
| Date Mfgr Received | 2013-06-03 |
| Device Manufacturer Date | 2004-02-24 |
| Date Added to Maude | 2013-09-20 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 RXL MAX W/O HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | LCD |
| Date Received | 2013-06-28 |
| Model Number | DIMENSION RXL MAX W/ HM |
| Device Availability | N |
| 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 | 2013-06-28 |