MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-05-16 for DIMENSION VISTA 500 manufactured by Siemens Healthcare Diagnostics Inc..
[75332336]
The customer contacted a siemens customer care center (ccc) specialist. The ccc was granted permission to dial in remotely to the instrument. The ccc reviewed the instrument's quality control (qc) data. The customer's qc was in range at the time of the event. The customer ran additional patient samples to confirm issue, no other samples showed discordance. The customer stated there may have been red blood cell debris in the sample in question, however this was unable to be confirmed. A siemens headquarters support center (hsc) reviewed the data provided. Hsc confirmed the issue. The cause of the discordant, falsely elevated blood urea nitrogen result is due to poor sample quality and presence of cellular material. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[75332337]
A discordant, falsely elevated blood urea nitrogen result was obtained on a patient sample on a dimension vista 500 instrument. The initial result was not reported out to the physician(s). The customer repeated the same sample on an alternate dimension vista instrument, resulting lower. The customer reported the repeat result to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated blood urea nitrogen result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2017-00491 |
| MDR Report Key | 6570579 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-05-16 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-04-16 |
| Date Mfgr Received | 2017-04-17 |
| Device Manufacturer Date | 2012-06-27 |
| Date Added to Maude | 2017-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY RICE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242406 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | REGISTRATION NUMBER: 1226181 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 | CDQ |
| Date Received | 2017-05-16 |
| Model Number | DIMENSION VISTA 500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Brand Name | DIMENSION VISTA 500 |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-05-16 |
| 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 | 500 GBC DRIVE PO BOX 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-16 |