MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-03-03 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics Inc.
[19021177]
A discordant, falsely elevated potassium (k) result was obtained on a dimension vista 1500 instrument for one patient. The discordant result was reported to the physician. The potassium sample was not reanalyzed as the sample was hemolyzed. The customer did not provide a result for the patient with a new sample without hemolyze. There are no known reports of patient intervention or adverse health consequences due to the discordant k result.
Patient Sequence No: 1, Text Type: D, B5
[19128993]
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 result was due to user error. The operator did not wait for the hemolysis, icterus, and lipemia index (hil) report before releasing the potassium result. The tsc instructed the customer on proper sample handling, specifically that the hil index is an indicator of sample quality for common interferences. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00109 |
| MDR Report Key | 3654256 |
| Report Source | 01,05,06 |
| Date Received | 2014-03-03 |
| Date of Report | 2014-02-05 |
| Date of Event | 2014-01-31 |
| Date Mfgr Received | 2014-02-05 |
| Device Manufacturer Date | 2013-01-30 |
| Date Added to Maude | 2014-05-12 |
| 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 | 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 | 2014-03-03 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 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 | 2014-03-03 |