MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-08 for DIMENSION EXL manufactured by Siemens Healthcare Diagnostics.
[19196523]
Discordant sodium (na) and potassium (k) results were obtained on a dimension exl instrument for three patients. The initial results were not reported to the physicians. The samples were retested and the repeated results were reported to the physicians. There are no known reports of patient intervention or adverse health consequences due to the discordant sodium and potassium results.
Patient Sequence No: 1, Text Type: D, B5
[19471444]
A siemens field service engineer (fse) was dispatched to the customer site and analyzed the instrument and instrument data. The fse determined that the cause of the discordant sodium and potassium results were due to user error; improper sample tube spinning. The tube vendor recommends pulling 100 - 1300 g force for 10 minutes in order to get a clean sample. Siemens instructed the customer to follow the tube manufacturer's recommendation for proper centrifugation times and speeds. The instrument is performing within specifications and further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2013-00210 |
| MDR Report Key | 3100871 |
| Report Source | 05,06 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-04-09 |
| Date of Event | 2013-04-05 |
| Date Mfgr Received | 2013-04-09 |
| Device Manufacturer Date | 2008-05-21 |
| Date Added to Maude | 2013-07-12 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOHN NELSON |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242530 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD |
| 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 EXL |
| Generic Name | CLINICAL CHEMISTRY SYSTEM |
| Product Code | NGS |
| Date Received | 2013-05-08 |
| Model Number | DIMENSION EXL |
| Operator | MEDICAL TECHNOLOGIST |
| 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 |
| Manufacturer Address | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-08 |