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 2014-11-18 for DIMENSION VISTA 1500 manufactured by Siemens Healthcare Diagnostics.
[5103428]
A discordant, falsely elevated potassium (k) result was obtained on one patient sample on a dimension vista 1500 instrument. It is unknown if the discordant k result was reported to the physician(s). The sample was repeated on the same instrument, resulting lower. The same sample was repeated two times on alternate instruments, both resulting lower. It is unknown as to which repeat result was reported to the physician(s). There are no known reports of adverse health consequences due to the discordant k result.
Patient Sequence No: 1, Text Type: D, B5
[12560191]
A siemens customer service engineer (cse) was dispatched to the customer site. After instrument and instrument data evaluation, the cse determined that there was no instrument malfunction during the time of the event. The headquarters support center determined that the potassium sample was processed pre-centrifuged, which indicates the sample underwent poor pre-analytical sample handling. The cause of the discordant potassium result is unknown. The customer successfully repeated the potassium result. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226181-2014-00594 |
| MDR Report Key | 4257071 |
| Report Source | 01,05,06 |
| Date Received | 2014-11-18 |
| Date of Report | 2014-10-21 |
| Date of Event | 2014-10-21 |
| Date Mfgr Received | 2014-10-21 |
| Device Manufacturer Date | 2010-08-19 |
| Date Added to Maude | 2014-11-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| 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 VISTA 1500 |
| Generic Name | CLINICAL CHEMISTRY SYSTEM |
| Product Code | MZV |
| Date Received | 2014-11-18 |
| Model Number | DIMENSION VISTA 1500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-11-18 |