MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-01-09 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc.
[17570842]
Discordant, falsely elevated potassium (k) results were obtained on a dimension vista 1500 instrument for one patient. The discordant results were not reported to the physician. The customer ran the sample two times on the same instrument and repeated the same sample two times on an alternate instrument. The corrected result was reported to the physician. There are no known reports of patient intervention or adverse health consequences due to the discordant k results.
Patient Sequence No: 1, Text Type: D, B5
[17784729]
A siemens technical service consultant (tsc) was contacted by the customer. The tsc evaluated the instrument data and determined that the cause of the discordant potassium results was due to poor sample quality: user error. The tsc determined that the sample was centrifuged for 3 minutes, that is outside the tube manufacturer's instructions for centrifugation. The tsc also determined that the sample was flagged with an above panic range flag and auto-repeated from the same aliquot space that also recovered falsely high. The tsc recommended that the customer review the proper pre-analytical sample handling procedures provided in the tube manufacturers instructions for use. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00014 |
| MDR Report Key | 3566655 |
| Report Source | 05,06 |
| Date Received | 2014-01-09 |
| Date of Report | 2013-12-14 |
| Date of Event | 2013-12-14 |
| Date Mfgr Received | 2013-12-14 |
| Device Manufacturer Date | 2009-06-08 |
| Date Added to Maude | 2014-04-09 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION VISTA 1500 |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | MZV |
| Date Received | 2014-01-09 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 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 | 2014-01-09 |