MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-12-16 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc.
[18768675]
The customer contacted the siemens technical solutions center (tsc). A global product support (gps) specialist evaluated the instrument data and did not find an instrument malfunction. The cause of the discordant, falsely low k results is unknown. It was discovered that the customer was centrifuging patient samples outside of the tube manufacturer specifications. The cause of the samples being centrifuged outside of tube vendor specifications is failure to follow instructions. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[18798343]
A discordant, falsely low potassium (k) result was obtained on one patient sample on a dimension vista 500 instrument. The discordant result was reported to the physician(s), who questioned it. The patient was redrawn and the new sample was tested on the same instrument, resulting higher. The redraw sample was then repeated in duplicate from both serum and plasma sample tubes on the same instrument with similar results. The original sample was then repeated in duplicate from both serum and plasma sample tubes on the same instrument, and the plasma tube resulted higher but the serum tube results matched the initial results. It is unknown if the corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low k result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2013-00546 |
| MDR Report Key | 3521790 |
| Report Source | 05,06 |
| Date Received | 2013-12-16 |
| Date of Report | 2013-11-21 |
| Date of Event | 2013-11-18 |
| Date Mfgr Received | 2013-11-21 |
| Device Manufacturer Date | 2010-10-13 |
| Date Added to Maude | 2014-03-26 |
| 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 AVE |
| 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 VISTA 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2013-12-16 |
| Model Number | DIMENSION VISTA 500 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2013-12-16 |